Mucositis: An INFLAMMATION of the MUCOSA with burning or tingling sensation. It is characterized by atrophy of the squamous EPITHELIUM, vascular damage, inflammatory infiltration, and ulceration. It usually occurs at the mucous lining of the MOUTH, the GASTROINTESTINAL TRACT or the airway due to chemical irritations, CHEMOTHERAPY, or radiation therapy (RADIOTHERAPY).Stomatitis: INFLAMMATION of the soft tissues of the MOUTH, such as MUCOSA; PALATE; GINGIVA; and LIP.Placebo Effect: An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.Mouth Mucosa: Lining of the ORAL CAVITY, including mucosa on the GUMS; the PALATE; the LIP; the CHEEK; floor of the mouth; and other structures. The mucosa is generally a nonkeratinized stratified squamous EPITHELIUM covering muscle, bone, or glands but can show varying degree of keratinization at specific locations.Double-Blind Method: A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.Treatment Outcome: Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series.Head and Neck Neoplasms: Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)Radiation Injuries: Harmful effects of non-experimental exposure to ionizing or non-ionizing radiation in VERTEBRATES.Radiotherapy: The use of IONIZING RADIATION to treat malignant NEOPLASMS and some benign conditions.Fluorouracil: A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid.Antineoplastic Combined Chemotherapy Protocols: The use of two or more chemicals simultaneously or sequentially in the drug therapy of neoplasms. The drugs need not be in the same dosage form.Drug Administration Schedule: Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.Mouthwashes: Solutions for rinsing the mouth, possessing cleansing, germicidal, or palliative properties. (From Boucher's Clinical Dental Terminology, 4th ed)Fibroblast Growth Factor 7: A fibroblast growth factor that is a specific mitogen for EPITHELIAL CELLS. It binds a complex of HEPARAN SULFATE and FIBROBLAST GROWTH FACTOR RECEPTOR 2B.Cross-Over Studies: Studies comparing two or more treatments or interventions in which the subjects or patients, upon completion of the course of one treatment, are switched to another. In the case of two treatments, A and B, half the subjects are randomly allocated to receive these in the order A, B and half to receive them in the order B, A. A criticism of this design is that effects of the first treatment may carry over into the period when the second is given. (Last, A Dictionary of Epidemiology, 2d ed)Combined Modality Therapy: The treatment of a disease or condition by several different means simultaneously or sequentially. Chemoimmunotherapy, RADIOIMMUNOTHERAPY, chemoradiotherapy, cryochemotherapy, and SALVAGE THERAPY are seen most frequently, but their combinations with each other and surgery are also used.Methotrexate: An antineoplastic antimetabolite with immunosuppressant properties. It is an inhibitor of TETRAHYDROFOLATE DEHYDROGENASE and prevents the formation of tetrahydrofolate, necessary for synthesis of thymidylate, an essential component of DNA.Antimetabolites, Antineoplastic: Antimetabolites that are useful in cancer chemotherapy.Dose-Response Relationship, Drug: The relationship between the dose of an administered drug and the response of the organism to the drug.Administration, Oral: The giving of drugs, chemicals, or other substances by mouth.Infusions, Intravenous: The long-term (minutes to hours) administration of a fluid into the vein through venipuncture, either by letting the fluid flow by gravity or by pumping it.Xerostomia: Decreased salivary flow.Leucovorin: The active metabolite of FOLIC ACID. Leucovorin is used principally as an antidote to FOLIC ACID ANTAGONISTS.Laser Therapy, Low-Level: Treatment using irradiation with LASER light of low power intensity so that the effects are not due to heat, as they are in LASER THERAPY.Glossitis: Inflammation of the tongue.Antineoplastic Agents: Substances that inhibit or prevent the proliferation of NEOPLASMS.Oral Ulcer: A loss of mucous substance of the mouth showing local excavation of the surface, resulting from the sloughing of inflammatory necrotic tissue. It is the result of a variety of causes, e.g., denture irritation, aphthous stomatitis (STOMATITIS, APHTHOUS); NOMA; necrotizing gingivitis (GINGIVITIS, NECROTIZING ULCERATIVE); TOOTHBRUSHING; and various irritants. (From Jablonski, Dictionary of Dentistry, 1992, p842)Benzydamine: A benzyl-indazole having analgesic, antipyretic, and anti-inflammatory effects. It is used to reduce post-surgical and post-traumatic pain and edema and to promote healing. It is also used topically in treatment of RHEUMATIC DISEASES and INFLAMMATION of the mouth and throat.Neutropenia: A decrease in the number of NEUTROPHILS found in the blood.Ageusia: Complete or severe loss of the subjective sense of taste, frequently accompanied by OLFACTION DISORDERS.Drug Evaluation: Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.Cisplatin: An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.Lichenoid Eruptions: Conditions in which there is histological damage to the lower epidermis along with a grouped chronic inflammatory infiltrate in the papillary dermis disturbing the interface between the epidermis and dermis. LICHEN PLANUS is the prototype of all lichenoid eruptions. (From Rook et al., Textbook of Dermatology, 4th ed, p398)Amifostine: A phosphorothioate proposed as a radiation-protective agent. It causes splenic vasodilation and may block autonomic ganglia.Drug Therapy, Combination: Therapy with two or more separate preparations given for a combined effect.Hematologic Neoplasms: Neoplasms located in the blood and blood-forming tissue (the bone marrow and lymphatic tissue). The commonest forms are the various types of LEUKEMIA, of LYMPHOMA, and of the progressive, life-threatening forms of the MYELODYSPLASTIC SYNDROMES.Neoplasms: New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.Thiotepa: A very toxic alkylating antineoplastic agent also used as an insect sterilant. It causes skin, gastrointestinal, CNS, and bone marrow damage. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), thiotepa may reasonably be anticipated to be a carcinogen (Merck Index, 11th ed).Oral Hemorrhage: Bleeding from the blood vessels of the mouth, which may occur as a result of injuries to the mouth, accidents in oral surgery, or diseases of the gums.Eriobotrya: A plant genus of the family ROSACEAE that is the source of an edible fruit. Members contain TRITERPENES.Hematopoietic Stem Cell Transplantation: Transfer of HEMATOPOIETIC STEM CELLS from BONE MARROW or BLOOD between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS). Hematopoietic stem cell transplantation has been used as an alternative to BONE MARROW TRANSPLANTATION in the treatment of a variety of neoplasms.Radiation-Protective Agents: Drugs used to protect against ionizing radiation. They are usually of interest for use in radiation therapy but have been considered for other, e.g. military, purposes.Radiodermatitis: A cutaneous inflammatory reaction occurring as a result of exposure to ionizing radiation.SucraseProspective Studies: Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group.Aminopterin: A folic acid derivative used as a rodenticide that has been shown to be teratogenic.Etoposide: A semisynthetic derivative of PODOPHYLLOTOXIN that exhibits antitumor activity. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA. This complex induces breaks in double stranded DNA and prevents repair by topoisomerase II binding. Accumulated breaks in DNA prevent entry into the mitotic phase of cell division, and lead to cell death. Etoposide acts primarily in the G2 and S phases of the cell cycle.Tolonium Chloride: A phenothiazine that has been used as a hemostatic, a biological stain, and a dye for wool and silk. Tolonium chloride has also been used as a diagnostic aid for oral and gastric neoplasms and in the identification of the parathyroid gland in thyroid surgery.Clinical Trials as Topic: Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.Anti-Infective Agents, Local: Substances used on humans and other animals that destroy harmful microorganisms or inhibit their activity. They are distinguished from DISINFECTANTS, which are used on inanimate objects.Hematologic Diseases: Disorders of the blood and blood forming tissues.Pilot Projects: Small-scale tests of methods and procedures to be used on a larger scale if the pilot study demonstrates that these methods and procedures can work.Time Factors: Elements of limited time intervals, contributing to particular results or situations.Drug-Related Side Effects and Adverse Reactions: Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.Cyclophosphamide: Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.Transplantation, Autologous: Transplantation of an individual's own tissue from one site to another site.Hematoxylin: A dye obtained from the heartwood of logwood (Haematoxylon campechianum Linn., Leguminosae) used as a stain in microscopy and in the manufacture of ink.Lasers, Semiconductor: Lasers with a semiconductor diode as the active medium. Diode lasers transform electric energy to light using the same principle as a light-emitting diode (LED), but with internal reflection capability, thus forming a resonator where a stimulated light can reflect back and forth, allowing only a certain wavelength to be emitted. The emission of a given device is determined by the active compound used (e.g., gallium arsenide crystals doped with aluminum or indium). Typical wavelengths are 810, 1,060 and 1,300 nm. (From UMDNS, 2005)Cryotherapy: A form of therapy consisting in the local or general use of cold. The selective destruction of tissue by extreme cold or freezing is CRYOSURGERY. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)Disease-Free Survival: Period after successful treatment in which there is no appearance of the symptoms or effects of the disease.Intestinal Mucosa: Lining of the INTESTINES, consisting of an inner EPITHELIUM, a middle LAMINA PROPRIA, and an outer MUSCULARIS MUCOSAE. In the SMALL INTESTINE, the mucosa is characterized by a series of folds and abundance of absorptive cells (ENTEROCYTES) with MICROVILLI.Severity of Illness Index: Levels within a diagnostic group which are established by various measurement criteria applied to the seriousness of a patient's disorder.Intestine, Small: The portion of the GASTROINTESTINAL TRACT between the PYLORUS of the STOMACH and the ILEOCECAL VALVE of the LARGE INTESTINE. It is divisible into three portions: the DUODENUM, the JEJUNUM, and the ILEUM.Melphalan: An alkylating nitrogen mustard that is used as an antineoplastic in the form of the levo isomer - MELPHALAN, the racemic mixture - MERPHALAN, and the dextro isomer - MEDPHALAN; toxic to bone marrow, but little vesicant action; potential carcinogen.Pain: An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.Carcinoma, Squamous Cell: A carcinoma derived from stratified SQUAMOUS EPITHELIAL CELLS. It may also occur in sites where glandular or columnar epithelium is normally present. (From Stedman, 25th ed)Follow-Up Studies: Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease.Transplantation Conditioning: Preparative treatment of transplant recipient with various conditioning regimens including radiation, immune sera, chemotherapy, and/or immunosuppressive agents, prior to transplantation. Transplantation conditioning is very common before bone marrow transplantation.Randomized Controlled Trials as Topic: Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.Taxoids: A group of diterpenoid CYCLODECANES named for the taxanes that were discovered in the TAXUS tree. The action on MICROTUBULES has made some of them useful as ANTINEOPLASTIC AGENTS.Radiation Injuries, Experimental: Experimentally produced harmful effects of ionizing or non-ionizing RADIATION in CHORDATA animals.Propantheline: A muscarinic antagonist used as an antispasmodic, in rhinitis, in urinary incontinence, and in the treatment of ulcers. At high doses it has nicotinic effects resulting in neuromuscular blocking.Doxorubicin: Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN.Diarrhea: An increased liquidity or decreased consistency of FECES, such as running stool. Fecal consistency is related to the ratio of water-holding capacity of insoluble solids to total water, rather than the amount of water present. Diarrhea is not hyperdefecation or increased fecal weight.Mucous Membrane: An EPITHELIUM with MUCUS-secreting cells, such as GOBLET CELLS. It forms the lining of many body cavities, such as the DIGESTIVE TRACT, the RESPIRATORY TRACT, and the reproductive tract. Mucosa, rich in blood and lymph vessels, comprises an inner epithelium, a middle layer (lamina propria) of loose CONNECTIVE TISSUE, and an outer layer (muscularis mucosae) of SMOOTH MUSCLE CELLS that separates the mucosa from submucosa.Nausea: An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.Serotonin 5-HT3 Receptor Agonists: Endogenous compounds and drugs that specifically stimulate SEROTONIN 5-HT3 RECEPTORS.Zinc Sulfate: A compound given in the treatment of conditions associated with zinc deficiency such as acrodermatitis enteropathica. Externally, zinc sulfate is used as an astringent in lotions and eye drops. (Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)Survival Analysis: A class of statistical procedures for estimating the survival function (function of time, starting with a population 100% well at a given time and providing the percentage of the population still well at later times). The survival analysis is then used for making inferences about the effects of treatments, prognostic factors, exposures, and other covariates on the function.Pain Measurement: Scales, questionnaires, tests, and other methods used to assess pain severity and duration in patients or experimental animals to aid in diagnosis, therapy, and physiological studies.Random Allocation: A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects.
Study 980231 (Randomized, double-blind, placebo-controlled). Three dose regimens were included: "pre-post", "pre", and placebo ... they usually get severe oral mucositis. Palifermin reduces the incidence and duration of severe oral mucositis by protecting ... Efficacy was demonstrated in the drug versus the placebo. Study 2000162 (Randomized, double-blind, placebo-controlled). ... Palifermin is also being studied in the prevention and treatment of oral mucositis and dysphagia (difficulty swallowing) in ...
... adverse events which occurred more often with sunitinib than placebo included diarrhea, anorexia, skin discoloration, mucositis ... of placebo patients (P=.006). Another 58% of sunitinib patients had disease stabilization vs. 48% of patients receiving placebo ... of patients who received placebo. Serious adverse events were reported in 20% of sunitinib patients and 5% of placebo patients ... At that time, patients receiving placebo were offered to switch over to sunitinib. In the primary endpoint of this study, ...
Clinical trial number NCT02324335 for "Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in ... who are receiving chemoradiation for head and neck cancer are randomized to receive either brilacidin-OM or the placebo three ... An active clinical trial, brilacidin for oral mucositis is detailed below. In pre-clinical research, a mouthwash formulation of ... Efficacy of Brilacidin Oral Rinse in Patients With Head and Neck Cancer The brilacidin trial for oral mucositis (Briladidin-OM ...
... for oral mucositis) (sold to Biovitrium, now Swedish Orphan Biovitrum, in December 2008) StemGen (Ancestim) (for use in ... reported positive results for brodalumab in a phase III trial comparing the compound with ustekinumab and a placebo in treating ... "are effective treatments compared with placebo for RA patients who are not well controlled by conventional DMARDs, improving ...
Oberoi, Sapna (2014-01-01). "Effect of prophylactic low level laser therapy on oral mucositis: a systematic review and meta- ... placebo-controlled clinical trial". Lasers in Medical Science 28 (3): 743-753. doi:10.1007/s10103-012-1129-9. ISSN 1435-604X. ...
Diarrhea Oral mucositis (mouth, throat, or lip sores). Oral ulcers can be mitigated by proper oral hygiene, including rinsing ... "Maintenance pemetrexed (Pem) plus best supportive care (BSC) versus placebo (Plac) plus BSC: A randomized phase III study in ...
Oral mucositis consists of inflammation of the mouth, along with sores and ulcers in the tissues. Healthy individuals normally ... was given a placebo for two months followed by a two-month treatment of ALA. The results reported show that 91% of the group ... Chemotherapy often induces damage to the oral cavity, resulting in oral mucositis, oral infection, and salivary gland ... fifty patients suffering from idiopathic dysgeusia were given either zinc or a lactose placebo. The patients prescribed the ...
... and oral mucositis. LLLT has been studied as a treatment for hair loss; a review in 2012 found little evidence to support the ... the hair grew back faster on mice he treated compared with the placebos. He published those results in 1967. He went on to show ... but in most cases no better than placebo, in relieving short-term pain for rheumatoid arthritis, osteoarthritis, acute and ... "Effect of prophylactic low level laser therapy on oral mucositis: a systematic review and meta-analysis". PLOS ONE. 9 (9): ...
One trail (Kerr 2010) assessed their effectiveness against a placebo disk. Strangely, patients from both groups (placebo and ... Mouth soreness and oral mucositis. Lipstick or food may stick to the teeth. A need to sip drinks frequently while talking or ... overall there is no strong evidence showing that Mucin Spray is more effective than a placebo in reducing the symptoms of dry ... it showed that Mucin Lozenges were ineffective when compared to a placebo. Mucoadhesive Disk: These disks are stuck to the ...
For example, it is possible through psychosurgery and some drug treatments, or by suggestion (as in hypnosis and placebo), to ... mucositis, joint pain, muscle pain, and abdominal pain due to diarrhea or constipation; hormone therapy, which sometimes causes ...
Other sources attribute the benefit to a simple placebo effect. Sanguinarine-containing mouthwashes are marketed as anti-plaque ... are used prior to and after oral surgery procedures such as tooth extraction or to treat the pain associated with mucositis ... Water Mouthrinse as Compared to Chlorhexidine and Placebo Rinses". Journal of Periodontology. 63 (1): 39-43. doi:10.1902/jop. ... that saline solution is just as effective as magic mouthwash in pain relief or shortening of healing time of oral mucositis ...
Burtness B, Goldwasser M, Flood W, Mattar B, Forastiere A (2005). "Phase III randomized trial of cisplatin plus placebo ... Eating problems Pain associated with lesions Mucositis Nephrotoxicity and ototoxicity Xerostomia Gastroesophageal reflux ...
Peri-Implant Mucositis. Peri-Implantitis. Peri-Implant Soft and Hard Tissue Deficiencies. [17] ... a pilot double blind randomized placebo-controlled clinical trial". BMC Oral Health. 16 (1): 57. doi:10.1186/s12903-016-0214-z ...
One trial (Kerr 2010) assessed their effectiveness against a placebo disk. Strangely, patients from both groups (placebo and ... Mouth soreness and oral mucositis.[1][3]. *Lipstick or food may stick to the teeth.[1] ... overall there is no strong evidence showing that Mucin Spray is more effective than a placebo in reducing the symptoms of dry ... it showed that Mucin Lozenges were ineffective when compared to a placebo.[8] ...
Effect of Prophylactic Low Level Laser Therapy on Oral Mucositis: A Systematic Review and Meta-Analysis. . Biblioteca virtual ... LLLT also reduced the following outcomes when compared to placebo-no therapy: severe mucositis at the time of anticipated ... overall mean grade of mucositis standardized mean difference −1.49, 95% CI −2.02 to −0.95, duration of severe mucositis ... was to determine whether prophylactic low level laser therapy LLLT reduces the risk of severe mucositis as compared to placebo ...
Treating radiodermatitis with LLLT is based on previously demonstrated decreased severity and duration of oral mucositis.32-34 ... a systematic review of possible mechanisms of action and clinical effects in randomized placebo-controlled trials. Photomed ... Low-level laser therapy in the management of mucositis and dermatitis induced by cancer therapy. Photomed Laser Surg. 2015;33( ... Clarkson JE, Worthington HV, Furness S, McCabe M, Khalid T, Meyer S. Interventions for treating oral mucositis for patients ...
Low-level laser for prevention and therapy of oral mucositis induced by chemotherapy or radiotherapy. Curr Opin Oncol. 2005;17( ... A systematic review and metaanalysis of randomised placebo-controlled trials. BMC Musculoskelet Disord. 2007;8:51.. 9. Hsieh ST ... However, a placebo-controlled, randomized, double-blind, multi-centered clinical investigation is warranted in order to ... Effects of low-level laser therapy on collagen expression and neutrophil infiltrate in 5-fluorouracil-induced oral mucositis in ...
PubMed journal article Randomized clinical trial of chlorhexidine versus placebo for prevention of oral mucositis in patients ... TY - JOUR T1 - Randomized clinical trial of chlorhexidine versus placebo for prevention of oral mucositis in patients receiving ... Randomized clinical trial of chlorhexidine versus placebo for prevention of oral mucositis in patients receiving chemotherapy. ... Randomized Clinical Trial of Chlorhexidine Versus Placebo for Prevention of Oral Mucositis in Patients Receiving Chemotherapy. ...
... oral hygiene program using water as a mouth rinse is cost efficient and may be effective in preventing oral mucositis. ... Randomized clinical trial of chlorhexidine versus placebo for prevention of oral mucositis in patients receiving chemotherapy ... Design: Randomized, double-blind, placebo-controlled, clinical trial. Settings: 23 outpatient clinics and office practices in ... Interestingly, the PSMA program appeared to reduce the incidence of mucositis from on a prior estimate of 44% to less than 26 ...
... a placebo-controlled double-blind randomized stud were found in PRIME PubMed. Download Prime PubMed App to iPhone or iPad. ... PubMed journal article Sucralfate mouth washing in the prevention of radiation-induced mucositis: ... Mucositis reduction by selective elimination of oral flora in irradiated cancers of the head and neck: a placebo-controlled ... Makkonen TA et al: "Sucralfate mouth washing in the prevention of radiation-induced mucositis: a placebo-controlled double- ...
... placebo-controlled trial. - Michelle Nottage, Sue-Anne McLachlan, Mary-Anne Brittain, Amit Oza, David Hedley, Ronald Feld, ... Sucralfate mouthwash for prevention and treatment of 5-fluorouracil-induced mucositis: a randomized, ... and the placebo-treated group. Some mucositis was reported by 79% of the patient group. Assessment of mucositis by trial staff ... Sucralfate mouthwash for prevention and treatment of 5-fluorouracil-induced mucositis: a randomized, placebo-controlled trial. ...
... of oral mucositis (painful sores in the mouth). Mucositis is a common side effect for patients receiving chemotherapy (cancer- ... Type: Placebo Comparator Description: Participants received a single IV dose of placebo three days before the start of ... of oral mucositis (painful sores in the mouth). Mucositis is a common side effect for patients receiving chemotherapy (cancer- ... The acute oral mucositis (OM) evaluation phase includes the time from randomization to the time of severe OM (WHO Grade 3 or 4 ...
Placebo Comparator: Placebo Intervention: Drug: Placebo. Publications * Not Provided. * Includes publications given by the data ... The Clinical Study for Evaluation of Efficacy and Safety of EGF on Oral Mucositis in Radiation Therapy Patients. The safety and ... The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation ... The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation ...
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Superoxide Dismutase Mimetic GC4419 to ... A Study to Investigate the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer. The safety ... Oral Mucositis. Superoxide Dismutase Mimetic. Cisplatin. Intensity-Modulated Radiation Therapy. Chemoradiation. OM. IMRT. Head ... Mucositis. Stomatitis. Neoplasms by Site. Neoplasms. Gastroenteritis. Gastrointestinal Diseases. Digestive System Diseases. ...
Placebo Comparator: Placebo toothpaste Fluoride toothpaste will be used by filling the individual silicone stent allowing it to ... Triclosan Toothpaste as a Preventive Strategy of Mucositis in Smokers. The safety and scientific validity of this study is the ... Triclosan Toothpaste as a Preventive Strategy of Mucositis in Smokers Official Title ICMJE Effect of a Triclosan-containing ... Other: Placebo toothpaste During an experimental 3-week period of undisturbed mechanical plaque accumulation in the implants, ...
Placebo Comparator: Placebo Patients are randomized 1:1 active/placebo.. Drug: Placebo Placebo is 0.9% sodium chloride (normal ... Squamous Cell Carcinoma of the Oral Cavity and Oropharynx Oral Mucositis Drug: SGX942 Drug: Placebo Phase 3 ... To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis (SOM; defined as World ... To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving ...
31% in the placebo group; PÂ = 0.007) and altered taste. Seven of the 8 patients who had severe mucositis in the placebo group ... In the placebo cycle, the median duration of grade 3 or 4 mucositis was 6 days (range, 3 to 12 days) and the median duration of ... Compared with placebo, palifermin reduced the cumulative incidence of moderate to severe (grade 2 or higher) mucositis (44% vs ... Eight of 16 patients (50%) in the placebo group had grade 3 or 4 mucositis. Of these, 7 received open-label palifermin in the ...
The purpose of this study is to evaluate the efficacy and effect of palifermin on the incidence of oral mucositis in subjec... ... and skeletal-related events compared with placebo... ... Palifermin Pre only, placebo, Palifermin Pre and Post. Status. ... Home » Topics » Multiple Myeloma » Research » A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With ... The purpose of this study is to evaluate the efficacy and effect of palifermin on the incidence of oral mucositis in subjects ...
Helping you find trustworthy answers on Oral Mucositis , Latest evidence made easy ... Find all the evidence you need on Oral Mucositis via the Trip Database. ... Randomized double-blind, placebo-controlled trial evaluating oral glutamine on radiation-induced oral mucositis and dermatitis ... 2. Oral mucositis Oral mucositis Oral mucositis - Symptoms, diagnosis and treatment , BMJ Best Practice Youll need a ...
... placebo-controlled, randomised trial of active manuka honey and standard oral care for radiation-induced oral mucositis. Br J ... A randomized placebo-controlled trial of manuka honey for radiation-induced oral mucositis. Support Care Cancer. 2014 Mar;22: ... Hinchazón (inflamación) y ampollas dentro de la boca (mucositis oral). El enjuague en la boca y luego otro enjuague con miel ... Hinchazón (inflamación) y ampollas dentro de la boca (mucositis oral): Se usó 20 mL de miel para enjuagar la boca 15 minutos ...
... placebo-controlled, randomised trial of active manuka honey and standard oral care for radiation-induced oral mucositis. Br J ... A randomized placebo-controlled trial of manuka honey for radiation-induced oral mucositis. Support Care Cancer. 2014 Mar;22: ... For swelling (inflammation) and sores inside the mouth (oral mucositis): Up to 15 grams of honey has been applied inside the ... For swelling (inflammation) and sores inside the mouth (oral mucositis): Honey 20 mL has been rinsed around the mouth 15 ...
To evaluate the preliminary efficacy of palifermin in reducing the incidence and severity of oral mucositis (OM) in patients w ... Grade 4: mucositis to extent alimentation not possible.. Outcome Time Frame:. Within 6 blinded cycles (3-week cycles), up to 18 ... the last dose of study drug (either palifermin or placebo) was given.. At your end of study visit, you will be evaluated for ... This will be done for 18 weeks (a total of 12 injections). A placebo is a. substance that looks like the study drug, but which ...
... placebo-controlled, double-blind clinical trial of curcuminoids in oral lichen planus.(Report) by Phytomedicine: International ... We developed this scale by modifying the oral mucositis index, which has been validated for use in measuring oral mucositis ... none on placebo, one on curcuminoids), dry mouth (two on placebo, one on curcuminoids), and metallic taste (one on placebo, ... "Other" side effects reported by study subjects included: headache (five on placebo, one on curcuminoids), rash (one on placebo ...
RATIONALE: Acupuncture may be effective in relieving mucositis-related pain caused by chemotherapy in patients undergoing stem ... A Randomized, Placebo-Controlled, Blinded Study Of Acupuncture Therapy In Mucositis-Related Pain In Patients Undergoing ... A Randomized, Placebo-Controlled, Blinded Study Of Acupuncture Therapy In Mucositis-Related Pain In Patients Undergoing ... Compare the efficacy of acupuncture vs placebo acupuncture in alleviating. mucositis-related pain secondary to high-dose ...
... the results were not deemed clinically different when compared with placebo. ... Use of two medicated mouthwashes reduced pain from oral mucositis during the first four hours after administration; however, ... was more effective than placebo (92 patients) in reducing oral mucositis pain for patients undergoing radiotherapy to the oral ... antacid mouthwash compared with placebo significantly reduced oral mucositis pain during the first four hours after ...
Cellceutix Reports Very Encouraging Interim Analysis Of Phase 2 Drug Candidate Brilacidin For Severe Oral Mucositis (OM) In ... Placebo): 7 of 10 patients (70 percent) ... Cellceutix: A New Standard Of Care In Oral Mucositis In The ... Cellceutix CEO Discusses Brilacidin Following Interim Trial Results For Treating Oral Mucositis And Inflammatory Bowel Disease ... Cellceutix To Present At Biotech Showcase 2017; Brilacidin For Oral Mucositis Nears Interim Results. ...
Randomized double-blind placebo-controlled trial of propolis for oral mucositis in patients receiving chemotherapy for head and ... Vynograd N, Vynograd I, Sosnowski Z. A comparative multi-centre study of the efficacy of propolis, acyclovir and placebo in the ... Propolis is also used topically as a mouth rinse to treat painful mouth sores and inflammation (oral mucositis) and thrush ( ... Propolis allergy: a cause of oral mucositis with ulceration. Oral Surg Oral Med Oral Pathol 1990;70:584-6. View abstract. ...
... the proportion of patients who get through stomatotoxic chemotherapy without developing ulcerative oral mucositis. An error in ... The study was powered to detect an increase in patients free of mucositis from 36% expected with placebo to 55% with iseganan. ... Bradford reported that the proportion of patients free of mucositis on day 21 was 33% with placebo vs 43% with iseganan. He ... iseganan reduced the average oral mucositis severity as defined by mean Oral Mucositis Assessment Scale (OMAS) score by 22% (P ...
Randomized, double blind, placebo-controlled, phase I/II study. Measurement Instruments/Methods: * NCI-CTC mucositis toxicity ... 2004). Phase I/II randomized trial evaluating the safety and clinical effects of repifermin administered to reduce mucositis in ... Assessments before HSCT regimen, day of transplant, and 3x/wk until mucositis resolved.. ...
RadiotherapyStomatitisSevere mucositisChemotherapy-induced mucositisIncidence of gradeNeutropeniaHigh-dose chemotherapyPreventionToxicityReduce mucositisMouthwashInduced by oral mucositisEvaluated for oral mucositisManagement of oral mucositisEither placeboUlcersClinical trialUnderestimated the incidenceOMASGradeSecondaryDurationInflammationBone marrow transplaRadiation mucositisIntestinal mucositisSignificantlySeverity of radiation inducedTreatmentPhaseDoseSymptomsSoresPalifermin or placeboMouthTherapyEfficacy
- Mucositis is a common side effect for patients receiving chemotherapy (cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and neck cancer (HNC). (ichgcp.net)
- In the acute OM evaluation phase, participants were randomized to receive either a single IV dose of palifermin or placebo at 180 μg/kg, 3 days before the start of radiotherapy, plus 7 once-weekly palifermin or placebo doses at the same dose level during a 7-week radio/chemotherapy course. (ichgcp.net)
- Open label palifermin will be administered to subjects who are at a risk of developing mucositis after radiotherapy and chemotherapy followed by blood stem cell support. (bioportfolio.com)
- Oral mucositis is a side effect from radiotherapy and chemotherapy, causing pain, and in turn, discontinuation of treatment for many with cancer. (curetoday.com)
- More than 80% of patients develop oral mucositis during radiotherapy, and mouthwashes and systemic analgesic agents are frequently used to treat the condition. (curetoday.com)
- So, the researchers conducted a randomized phase 3 trial designed to evaluate whether a single dose of doxepin mouthwash (92 patients) or diphenhydramine-lidocaine-antacid mouthwash (92 patients) was more effective than placebo (92 patients) in reducing oral mucositis pain for patients undergoing radiotherapy to the oral cavity for head and neck cancer treatment. (curetoday.com)
- Ulcerative oral mucositis is a frequent, debilitating, and sometimes dose-limiting complication of chemotherapy and radiotherapy. (cancernetwork.com)
- Previous studies suggested that selective oral decontamination can reduce mucositis severity after radiotherapy. (cancernetwork.com)
- Oral mucositis is an adverse event (AE) frequently induced by radiotherapy and chemotherapy during cancer treatment. (biomedcentral.com)
- Approximately 600,000 patients worldwide are currently undergoing cancer treatment with radiotherapy and/or chemotherapy, and are at risk of developing oral mucositis [ 3 ]. (biomedcentral.com)
- Oral mucositis results from direct cell injury caused by chemotherapy or radiotherapy. (biomedcentral.com)
- Genot-Klastersky MT, Klastersky J, Awada F et al (2008) The use of low-energy laser (LEL) for the prevention of chemotherapy- and / or radiotherapy-induced oral mucositis in cancer patients : results from two prospective studies. (springer.com)
- A new suggestion was made for low-level laser (wavelength around 632.8 nm) for the prevention of oral mucositis in patients undergoing radiotherapy, without concomitant chemotherapy, for head and neck cancer. (springer.com)
- Mucositis is a common, painful, treatment-disrupting toxicity of both radiotherapy and chemotherapy. (springer.com)
- Effect of doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash vs placebo on radiotherapy-related oral mucositis pain. (mayoclinic.org)
- 1 This guideline for the prevention of oral and oropharyngeal mucositis was developed in order to prevent or reduce the severity of mucositis in children 0-18 years of age receiving cytotoxic chemotherapy or radiotherapy for cancer or undergoing HSCT. (bmj.com)
- A mouthwash containing calendula was shown useful for reducing dental plaque and gingivitis adjunctive to scaling (25) , for reducing chemotherapy-induced stomatitis (17) , but was ineffective in preventing mucositis associated with chemo-radiotherapy (26) . (mskcc.org)
- Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer. (jefferson.edu)
- Photobiomodulation (PBM) is emerging as an effective strategy for the management of multiple inflammatory conditions, including oral mucositis (OM) in cancer patients who receive chemotherapy or radiotherapy. (hindawi.com)
- In another trial the duration of pain relief after morphine mouthwash in patients with radiotherapy- and chemotherapy-induced oral mucositis was around 120 min . (termedia.pl)
- A rigorous, intention-to-treat efficacy analysis that included the improperly treated patients still showed that iseganan significantly decreased mouth pain and stomatitis compared to placebo, and that the increase in the proportion of patients without ulcerative mucositis approached statistical significance ( P = 0.067). (cancernetwork.com)
- We also suggest KGF may be offered to children receiving HSCT conditioning with regimens associated with a high rate of severe mucositis. (bmj.com)
- Evaluation of GMCSF mouthwash for prevention of chemotherapy-induced mucositis: a randomized, double-blind, dose-ranging study. (koreascience.or.kr)
- The primary end point was the incidence of grade 3-4 oral mucositis. (knowcancer.com)
- At entry, patients were over age 7 years, free of mucositis, and scheduled to receive a chemotherapy regimen associated with a greater than 50% incidence of grade 2 or worse oral mucositis. (cancernetwork.com)
- The primary endpoint was the incidence of grade ≥ 3 oral mucositis determined by clinical examination and assessed by central review according to the Common Terminology Criteria of Adverse Events version 3.0. (biomedcentral.com)
- The incidence of grade ≥ 3 oral mucositis was 29% and 25% in the rebamipide 2% and 4% groups, respectively, compared with 39% in the placebo group. (biomedcentral.com)
- The European Medicine Agency (EMEA)'s decision is based on a pivotal Phase III double-blind study which found that Kepivance reduced the incidence of grade 4 oral mucositis to 20% from 62% in the placebo arm. (pharmatimes.com)
- Systemic hematogenous dissemination of mouse oral candidiasis is induced by oral mucositis The causes of fungemia include immunosuppression and neutropenia stemming from diverse factors as well as the placement of central venous catheters. (tripdatabase.com)
- Higher rates of neutropenia, mucositis, and transaminase elevation were seen with everolimus. (aacrjournals.org)
- Secondary endpoints evaluated included duration of oral mucositis, patient self-reported pain score, use of pain medications, the incidence and duration of febrile neutropenia, and use of enteral or parenteral nutrition. (bio-medicine.org)
- Common grade 3 or 4 treatment-related adverse events included hand-foot skin reaction, diarrhea, dyspnea, neutropenia and mucositis. (drugs.com)
- The GOELAMS investigators randomly assigned 67 subjects to receive GM-CSF or placebo during induction chemotherapy with idarubicin, methylprednisolone, and high-dose Ara-C and observed no difference in the CR rate, the duration of neutropenia, or days with fever for the two groups. (medscape.com)
- Prophylaxis with GM-CSF mouthwashes does not reduce frequency and duration of severe oral mucositis in patients with solid tumors undergoing high-dose chemotherapy with autologous peripheral blood stem cell transplantation rescue: a double blind, randomized, placebo-controlled study. (koreascience.or.kr)
- When patients with blood cancers (leukemia and lymphoma) receive high dose chemotherapy and radiation therapy to undergo bone marrow transplantation, they usually get severe oral mucositis. (wikipedia.org)
- A randomized, double-blind, placebo-controlled trial of misoprostol for oral mucositis secondary to high-dose chemotherapy. (nih.gov)
- In particular, mucositis is prevalent in patients undergoing high-dose chemotherapy, and 80 percent of individuals with head and neck cancers. (naturalnews.com)
- CLN-12 was a randomized, double-blind, placebo-controlled study designed to assess a reduction in the incidence of severe Grade 3 or 4 oral mucositis in patients receiving high-dose chemotherapy followed by autologous bone marrow transplantation (BMT). (bio-medicine.org)
- Based on our experience with velafermin in Phase I, we are pleased to be taking part in the Phase II trial to evaluate this investigational drug for the prevention of OM," stated Michael W. Schuster, M.D. "Oral mucositis is a severe side effect that frequently occurs as a result of the high-dose chemotherapy administered to patients prior to bone marrow transplantation. (rxpgnews.com)
- Data on 30 patients dosed with velafermin (CG53135) were presented in a poster entitled, "Phase I Trial of CG53135-05 (Velafermin) to Prevent Mucositis in Patients Undergoing High-dose Chemotherapy (HDCT) and Autologous Peripheral Blood Stem Cell Transplantation (PBSCT). (rxpgnews.com)
- Sucralfate mouth washing in the prevention of radiation-induced mucositis: a placebo-controlled double-blind randomized study. (unboundmedicine.com)
- To evaluate the value of sucralfate mouth washings in prevention of radiation-induced mucositis. (unboundmedicine.com)
- TY - JOUR T1 - Sucralfate mouth washing in the prevention of radiation-induced mucositis: a placebo-controlled double-blind randomized study. (unboundmedicine.com)
- Sucralfate mouthwash for prevention and treatment of 5-fluorouracil-induced mucositis: a randomized, placebo-controlled trial. (curehunter.com)
- Eilers J, Million R (2011) Clinical update: prevention and management of oral mucositis in patients with cancer. (springer.com)
- Bensadoun R-J, Nair RG (2012) Low-level laser therapy in the prevention and treatment of cancer therapy-induced mucositis. (springer.com)
- The aim of this study was to review the available literature and define clinical practice guidelines for the use of laser and other light therapies for the prevention and treatment of oral mucositis. (springer.com)
- This manuscript is part of a collaborative effort of the Mucositis Study Group of the Multinational Association of Supportive Care in Cancer (MASCC) and the International Society of Oral Oncology (ISOO) to update the existing guidelines for the prevention and treatment of oral mucositis (OM) in cancer patients. (springer.com)
- Palifermin is also being studied in the prevention and treatment of oral mucositis and dysphagia (difficulty swallowing) in other types of cancer. (wikipedia.org)
- This chapter discusses the clinical characteristics of mucositis, how it is evaluated and scored, its pathogenesis, and current and evolving prevention and treatment strategies. (springer.com)
- Nursing interventions and supportive care for the prevention and treatment of oral mucositis associated with cancer treatment. (springer.com)
- Updated clinical practice guidelines for the prevention and treatment of mucositis. (springer.com)
- SCLN ) today announced the enrollment of its first patient in its phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of SCV-07 for prevention of oral mucositis (OM) in patients receiving radio-chemotherapy for the treatment of head and neck cancer. (marketwired.com)
- Data from the preclinical studies of SCV-07 were very promising, showing a compelling prevention of oral mucositis. (marketwired.com)
- Based on these significant findings, we believe that further studies of SCV-07 for the prevention of oral mucositis in head and neck cancer patients are warranted. (marketwired.com)
- For more information on SciClone's phase 2 trial of SCV-07 in the prevention of oral mucositis, please visit www.clinicaltrials.gov . (marketwired.com)
- The decrease in growth of tumors and increase in survival rates seen in these preclinical cancer models suggest that the use of SCV-07 in this new clinical study, i.e., the prevention of radio-chemotherapy induced oral mucositis, could also have the added benefit of positive effects against the primary tumor. (marketwired.com)
- CRGN ), a clinical-stage biopharmaceutical company focused on oncology, announced today that its Phase II dose-confirmatory clinical trial (CLN-12) evaluating a single dose of velafermin for the prevention of severe oral mucositis demonstrated that velafermin was safe and well-tolerated but did not meet its primary endpoint. (bio-medicine.org)
- Based on results from Phase I, the 0.03, 0.1 and 0.2 mg/kg single doses of velafermin (CG53135) are currently being evaluated in a randomized, double- blind, placebo-controlled, multi-center Phase II clinical trial for the prevention of OM in approximately 200 patients receiving HDCT followed by AHSCT. (rxpgnews.com)
- Antioxidant capacity of calendula officinalis flowers extract and prevention of radiation induced oropharyngeal mucositis in patients with head and neck cancers: A randomized controlled clinical study. (ons.org)
- Purpose To develop an evidence-based clinical practice guideline for the prevention of oral mucositis in children (0-18 years) receiving treatment for cancer or undergoing haematopoietic stem cell transplantation (HSCT). (bmj.com)
- Methods The Mucositis Prevention Guideline Development Group was interdisciplinary and included internationally recognised experts in paediatric mucositis. (bmj.com)
- No other interventions were recommended for oral mucositis prevention in children. (bmj.com)
- Cellceutix is planning a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. (marketwired.com)
- Additionally, oral mucositis is a risk factor for sepsis in patients with low neutrophil count secondary to cancer treatment toxicity. (biomedcentral.com)
- PURPOSE: Oral mucositis (OM) remains a common, debilitating toxicity of radiation therapy (RT) for head and neck cancer. (jefferson.edu)
- A variety of DS may provide benefits to cancer patients, facilitating relief from such cancer-treatment associated symptoms such as mucositis, intestinal toxicity, neuropathy, and nausea. (bioscience.org)
- There are several different mouthwashes in use to reduce mucositis pain from radiation and chemotherapy. (cancerconnect.com)
- Random assignment to a mouthwash occurred prior to the development of oral mucositis. (unboundmedicine.com)
- Type of mouthwash, incidence, days to onset, and severity of chemotherapy-induced oral mucositis. (unboundmedicine.com)
- Mucositis pain during the first 4 hours decreased by 11.6 points in the doxepin mouthwash group, by 11.7 points in the diphenhydramine- lidocaine-antacid mouthwash group and by 8.7 points in the placebo group, for a 2.9-point difference between doxepin mouthwash and placebo and a 3.0-point difference between diphenhydramine- lidocaine-antacid mouthwash and placebo. (curetoday.com)
- Patients who received doxepin mouthwash reported more drowsiness (by 1.5 points), unpleasant taste (by 1.5 points) and stinging or burning (by 4.0 points) compared with placebo. (curetoday.com)
- Grade 3 side effects occurred in three patients who received the doxepin mouthwash, three patients with the diphenhydramine-lidocaine-antacid mouthwash and two patients with placebo. (curetoday.com)
- The phase III trial reported at ASCO was designed to further evaluate the safety and efficacy of an iseganan mouthwash in reducing the incidence of ulcerative oral mucositis and its clinical sequelae, including pain, difficulty swallowing, fevers, and systemic infections. (cancernetwork.com)
- Magic Mouthwash'- a mixture of diphenhydramine, lidocaine plus an antacid is used by many cancer centers and reduces oral mucositis pain when used in patients receiving radiation therapy for the treatment of head and neck cancer or those undergoing stem cell transplant. (cancerconnect.com)
- 3 to be treated with doxepin mouthwash or placebo ~ 2-3 weeks after initiation of therapy. (cancerconnect.com)
- Results showed those who received the mouthwash experienced an 11.7-point decrease in mucositis pain during the first 4 hours after treatment, compared an 8.7-point decrease with placebo. (cancerconnect.com)
- This is the second clinical trial showing that doxepin mouthwash relieved chemoradiotherapy-related oral mucositis pain. (cancerconnect.com)
- Magic mouthwash,' an oral rinse containing diphenhydramine, lidocaine and antacids, significantly reduced pain from oral mucositis, mouth sores, in patients receiving radiation therapy for cancers of the head and neck when compared to plaecbo. (news-medical.net)
- They found that pain related to oral mucositis was significantly less following both doxepin and magic mouthwash rinses versus placebo. (news-medical.net)
- Patients were randomly assigned to either the calendula mouthwash group or a placebo group. (ons.org)
- The authors of the study concluded: "According to the findings in this study, omega-3 fatty acids in oral form have a significant effect on wound healing induced by oral mucositis. (naturalnews.com)
- Some agents targeting these underlying mechanisms have been evaluated for oral mucositis treatment. (biomedcentral.com)
- COMMENTING ON the results of this trial of GC4419, Rajesh V. Lalla, DDS, PhD, President of the Multinational Association of Supportive Care in Cancer, said, "This study demonstrated this agent's strong potential for the management of oral mucositis in patients receiving head and neck radiation. (ascopost.com)
- Patients were issued drug bottles containing a 5-day supply of either placebo or iseganan. (cancernetwork.com)
- Patients (N = 66) were randomly assigned to receive either placebo or IM (4 mg/day for 14 consecutive days). (ovid.com)
- Study subjects were randomized to receive either placebo or curcuminoids at 2000 mg/day for 7 weeks. (thefreelibrary.com)
- Each cohort will receive either placebo, SCV-07 at a dose of 0.02 mg/kg, or SCV-07 at a dose of 0.10 mg/kg. (marketwired.com)
- Patients enrolled in the trial were randomized to receive a single infusion of either placebo or one of three dose levels of velafermin (10 mcg/kg, 30 mcg/kg or 60 mcg/kg) administered 24 hours after BMT. (bio-medicine.org)
- Sometimes, this also leads to mucositis, or mouth sores and ulcers. (cureourchildren.org)
- Treatment for cancer (including bone marrow transplant) can cause oral mucositis (severe ulcers in the mouth). (cochrane.org)
- One of these side effects is oral mucositis (mouth ulcers). (cochrane.org)
- Mucositis is characterized by soreness or swelling in the mouth which can result in painful ulcers in the area. (naturalnews.com)
- Aside from the formation of ulcers, people with mucositis experience severe pain, an increased risk of local and systemic infections, dysfunction, and bleeding from the mouth, oral cavity and pharynx - all of which could affect a person's quality of life. (naturalnews.com)
- Two physicians performed mucositis grading and grading of oral ulcers. (ons.org)
- In a short randomized, placebo-controlled, crossover study of topically applied morphine as a treatment for painful leg ulcers, there was a statistically significant difference only 2 h after dressing on the first treatment occasion . (termedia.pl)
- The aim of this study was to assess the effectiveness and safety of topical morphine for the treatment of pain caused by mucosal lesions (0.2% hydrogel) and skin ulcers (0.2% ointment) in comparison to placebo in adult cancer patients treated with systemic opioids. (termedia.pl)
- Add in the potential of Brilacidin for oral mucositis, diabetic foot ulcers, and eye and ear diseases, and you can understand what a game changer this drug alone brings to Cellceutix shareholders. (marketwired.com)
- A randomized, placebo-controlled, double-blind clinical trial of curcuminoids in oral lichen planus. (thefreelibrary.com)
- Validation of a new scoring system for the assessment of clinical trial research of oral mucositis induced by radiation or chemotherapy. (springer.com)
- This was shown in a large, Phase III clinical trial in which patients who failed imatinib therapy (due to primary resistance, secondary resistance, or intolerance) were treated in a randomized and blinded fashion with either sunitinib or placebo. (wikipedia.org)
- Assessment of mucositis by trial staff underestimated the incidence of this problem. (curehunter.com)
- Oral mucositis evaluation was done by WHO and Oral Mucositis Assessment Scale (OMAS) scale. (knowcancer.com)
- We used the scales of mucositis of the World Health Organization (WHO) and the Oral Mucositis Assessment Scale (OMAS) and a visual analogue scale (VAS) for pain assessment. (knowcancer.com)
- Dr. Bradford said that in a phase II trial of patients receiving myeloablative chemotherapy and bone marrow transplantation, iseganan reduced the average oral mucositis severity as defined by mean Oral Mucositis Assessment Scale (OMAS) score by 22% ( P = 0.049) in the 134 evaluable patients and by 40% ( P = 0.047) in the 76 patients who started IB-367 more than 3 days prior to transplantation. (cancernetwork.com)
- The Oral Mucositis Assessment Scale (OMAS) was used. (ons.org)
- The acute oral mucositis (OM) evaluation phase includes the time from randomization to the time of severe OM (WHO Grade 3 or 4) resolution (up to Week 12 or up to Week 15 for participants whose severe OM is not resolved at Week 12). (ichgcp.net)
- Secondary endpoints were the time to onset of grade ≥ 3 oral mucositis and the incidence of functional impairment (grade ≥ 3) based on the evaluation by the Oral Mucositis Evaluation Committee. (biomedcentral.com)
- The proportion of patients who did not develop grade ≥ 3 oral mucositis by day 50 of treatment was 57.9% in the placebo group, whereas the proportion was 68.0% in the rebamipide 2% group and 71.3% in the rebamipide 4% group. (biomedcentral.com)
- A Grade II mucositis, according to the World Health Organization, was found in 25 patients, and the treatment was interrupted for 7-10 days in 5. (curehunter.com)
- To evaluate their theory, they conducted a randomized trial using patients that had grade 1 oral mucositis. (naturalnews.com)
- In this study, 34% of sunitinib patients reported any grade of fatigue, compared with 22% for placebo. (wikipedia.org)
- [ 82 ] In addition, mucositis of higher than grade 3 was reduced in subjects receiving GM-CSF (two of 35 patients vs six of 29 patients, respectively. (medscape.com)
- Grade 3-4 hypertension occurred in 9% of niraparib- treated patients compared with 2% of patients assigned to placebo. (fda.gov)
- Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI]. (rochester.edu)
- Currently, the most prescribed treatment for inflammation secondary to mucositis relies on the use of corticosteroids in the oral, injection and topical forms as well as orally administered NSAIDs. (scirp.org)
- The purpose of this research study is to test the safety and effectiveness of palifermin to determine if weekly doses can be safely administered to reduce the incidence (occurrence of), duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in the mouth). (ichgcp.net)
- Duration of severe oral mucositis (SOM) [ Time Frame: approx. (clinicaltrials.gov)
- Decrease of duration and symptoms in chemotherapy-induced oral mucositis by topical GM-CSF: results of a prospective randomised trial. (koreascience.or.kr)
- Palifermin reduces the incidence and duration of severe oral mucositis by protecting those cells and stimulating the growth of new epithelial cells to build up the mucosal barrier. (wikipedia.org)
- The primary endpoint was duration of SOM tested for each active dose level versus placebo (intent-to-treat population, two-sided α of .05). (jefferson.edu)
- The median duration of prednisone treatment was significantly shorter in the methotrexate group than in the placebo group (29 v. 94 weeks, p = 0.0016), resulting in a lower mean cumulative dose of prednisone (4187 v. 5489 mg, p = 0.009). (cmaj.ca)
- In addition to demonstrating a reduction in the median duration of severe oral mucositis in these patients, dusquetide treatment was also associated with a reduced incidence of reported infections. (biospace.com)
- BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search Oral mucositis Last reviewed: February 2019 Last updated: June 2018 Summary An acute inflammation of the oral mucosa following systemic chemotherapy and/or radiation. (tripdatabase.com)
- Honey is most commonly used for burns, wound healing, swelling (inflammation) and sores inside the mouth (oral mucositis), and cough. (medlineplus.gov)
- Propolis is also used topically as a mouth rinse to treat painful mouth sores and inflammation (oral mucositis) and thrush (oropharyngeal candidiasis) and to improve healing following oral surgery. (webmd.com)
- Painful mouth sores and inflammation (oral mucositis). (webmd.com)
- Oral mucositis (OM) is a severe inflammation of the oral and oropharyngeal mucosa, leading to the development of extensive erythema and ulcerations. (hindawi.com)
- A scoring system for the quantitative evaluation of oral mucositis during bone marrow transplantation. (springer.com)
- Assessment of the degree of radiation mucositis and collection of stimulated saliva samples were done weekly during the therapy. (unboundmedicine.com)
- While the etiology and the pathogenic mechanisms of OM have not been fully elucidated yet, several studies have reported a major role of DNA damage and reactive oxygen species (ROS) during the early phases of oral and intestinal mucositis [ 4 - 7 ]. (hindawi.com)
- IM significantly reduced the incidence and maximum severity of oral mucositis in patients treated with 5-FU-chemotherapy. (ovid.com)
- Conditional power calculations suggested a less than 2% chance that the curcuminoids group would have a significantly better outcome as compared with the placebo group if the trial were continued to completion. (thefreelibrary.com)
- In addition, people who were given omega-3 fatty acids had significantly lower severity of mucositis compared to those in the placebo group. (naturalnews.com)
- Irritation sores from mucositis were also noted to be significantly different in both groups as well. (naturalnews.com)
- However, patients receiving drug treatment had a significantly reduced risk of death (HR 0.78, 95% CI 0.64 to 0.96, P =0.02), and median progression-free survival for patients receiving pemetrexed was 4.1 months versus 2.8 months with placebo. (medpagetoday.com)
- The purpose of the phase 3, clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck. (clinicaltrials.gov)
- Treatment for mucositis consists of supportive therapies, such as mouthwashes, aimed at reducing discomfort until the cells regenerate themselves and cryotherapy (ice chips) although new medications are under investigation. (cancerconnect.com)
- GM-CSF mouthrinses in the treatment of severe oral mucositis: a pilot study. (koreascience.or.kr)
- Ribeiro ILA, Limeira RRT, de Castro RD, Bonan PRF, Valença AMG (2017) Oral mucositis in pediatric patients in treatment for acute lymphoblastic leukemia. (springer.com)
- Chaveli-López B, Bagán-Sebastián JV (2016) Treatment of oral mucositis due to chemotherapy. (springer.com)
- While palifermin is the only agent currently approved for treatment, it also represents an example of other agents in development for which efficacy is based on disruption of the biological pathways leading to mucositis. (springer.com)
- We are therefore excited to continue exploring SCV-07's potential in preventing oral mucositis in addition to carrying out our ongoing clinical investigation of SCV-07 in the treatment of patients with chronic hepatitis C infection. (marketwired.com)
- Treatment with tivozanib increased 12-week progression-free survival by almost 60% compared with placebo, Pankaj Bhargava, M.D., of Aveo Pharmaceuticals in Cambridge, Mass., reported here at the American Society of Clinical Oncology meeting. (medpagetoday.com)
- About 83% of sunitinib patients experienced a treatment-related adverse event of any severity, as did 59% of patients who received placebo. (wikipedia.org)
- No patients in the treatment group required medication for OM, and radiation was not stopped for mucositis. (ons.org)
- The 539 patients whose disease did not progress during the dual-treatment segment were randomized two-to-one to pemetrexed maintenance or placebo. (medpagetoday.com)
- Both study arms received best supportive care in addition to drug or placebo treatment. (medpagetoday.com)
- Compared with placebo, pemetrexed treatment benefit was modest -- 44% of pemetrexed-treated patients achieved a complete or partial response to induction therapy versus 42% of patients, while 53% of patients receiving drug therapy and placebo had stable disease after sham or drug treatment. (medpagetoday.com)
- SAN FRANCISCO-Phase III data show that iseganan, a selectively decontaminating rinse for the oral mucosa, increases by at least 30% the proportion of patients who get through stomatotoxic chemotherapy without developing ulcerative oral mucositis. (cancernetwork.com)
- Patients with stage II/III TNBC were enrolled in a randomized phase II trial of preoperative weekly cisplatin, paclitaxel and daily everolimus or placebo for 12 weeks, until definitive surgery. (aacrjournals.org)
- Palifermin (180 µg per kg of body weight) or placebo was administered intravenously as a single dose 3 days before each chemotherapy cycle (maximum, 6 cycles). (annals.org)
- Total pain reduction during the four hours after a single dose of the mouthwashes compared with placebo served as the primary endpoint, with a minimal clinically important difference being a 3.5-point change. (curetoday.com)
- The mouth-rinse with G-CSF at a dose of 150-300ug plus 100ml-500ml normal saline was started from the time of oral mucositis was confirmed and continuously used for at least 7 days as one course. (koreascience.or.kr)
- Symptoms can be severe, and oral mucositis can lead to hospitalization and requirement of a feeding tube," the researchers wrote. (curetoday.com)
- Through the binding of this drug to the aforementioned receptor, Palifermin stimulates epithelial cell proliferation, differentiation, and upregulation of cytoprotective mechanisms to reduce the symptoms of oral mucositis. (wikipedia.org)
- Mouth sores (oral mucositis) can be extremely painful and can result in an inability to eat, speak or swallow. (mayoclinic.org)
- 48 patients with sarcoma were randomly assigned in a 2:1 ratio to receive palifermin or placebo. (annals.org)
- To test the effectiveness of a nurse-initiated systematic oral hygiene teaching program-PRO-SELF: Mouth Aware (PSMA)-in conjunction with two mouthwashes (0.12% chlorhexidine or sterile water) in preventing chemotherapy-induced oral mucositis. (unboundmedicine.com)
- A nursing prescription of a systematic oral hygiene program using water as a mouth rinse is cost efficient and may be effective in preventing oral mucositis. (unboundmedicine.com)
- Although the trial produced no direct clinical evidence indicating that sucralfate mouth rinses prevent radiation-induced mucositis, the decrease in the salivary lactoferrin and albumin levels suggests that sucralfate has a slight protective effect on the oral mucosa. (unboundmedicine.com)
- Chemotherapy- or radiation-induced damage to the cells lining the mouth, throat and gastrointestinal (GI) tract is called mucositis. (cancerconnect.com)
- Objective: To assess the safety and effectiveness of a mouth-rinse with G-CSF (JiSaiXin, produced by NCPC Biotechnology Co., Ltd) in treating patients with chemotherapy-induced oral mucositis (CIM). (koreascience.or.kr)
- Radiation to the head and neck, especially when it includes the tissues of the mouth, pharynx and hypopharynx, almost always results in significant oral mucositis. (marketwired.com)
- Radiation therapy causes many side effects especially oral mucositis. (clinicaltrials.gov)
- Among patients with multiple myeloma, is bisphosphonate therapy associated with lower rates of mortality, vertebral fractures, nonvertebral fractures, and skeletal-related events compared with placebo. (bioportfolio.com)
- Nine percent of sunitinib patients and 8% of placebo patients discontinued therapy due to an adverse event. (wikipedia.org)
- Patients were randomized (2:1) within 8 weeks of the last therapy to either niraparib (300 mg orally daily) or matched placebo. (fda.gov)
- The primary efficacy endpoint was a Kaplan-Meier estimate of the proportion of patients not developing ulcerative oral mucositis through study day 21. (cancernetwork.com)
- The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. (rochester.edu)
- Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, melioidosis, macrophage activation syndrome (MAS) and other bacterial infections. (biospace.com)