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Mucositis clinical trials

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NCT ID: NCT03778008 Not yet recruiting - Stomatitis Clinical Trials

Recombinant Bovine Basic Fibroblast Growth Factor for the Treatment of Radiation Induced Oral Mucositis

Start date: December 21, 2018
Phase: Phase 2
Study type: Interventional

Radiation therapy is one of the treatments for Nasopharyngeal carcinoma . The most common side effects of post-radiation may be radiation-induced oral mucositis . When severe, oral mucositis increases the risk of infection and may affect clinical outcomes due to treatment interruption, dose reduction, and reduced treatment compliance. In China, a quadruple mixture of dexamethasone, gentamicin, vitamin B12, and lidocaine is commonly used in patients who begin to have radiation-induced oral mucositis . However, the incidence of radiation-induced oral mucositis remains high. Recombinant bovine basic fibroblast growth factor is a multifunctional cell growth factor that stimulates the growth of cells derived from mesoderm and neuroectodermal cells and thus has a wide range of biological activities. The drug has different degrees of promotion on the three stages of the wound repair process, namely the local inflammatory reaction stage, cell proliferation and differentiation, granulation tissue formation stage and tissue reconstruction stage. The purpose of this randomized controlled trial was to evaluate the efficacy of recombinant bovine basic fibroblast growth factor as an intervention in radiation-induced oral mucositis for the treatment of nasopharyngeal carcinoma , with a commonly used quadruple mixture (from dexamethasone, gentamicin , vitamin B12 and lidocaine composition) were compared.

NCT ID: NCT03518489 Not yet recruiting - Clinical trials for Radiation Induced Oral Mucositis

Appaconitine Patch for Oral Mucositis Pain Caused by Chemoradiotherapy in Patients With Nasopharyngeal Cancer

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to evaluate the efficacy of lappaconitine adhesive patch in alleviation radiation induced mucositis pain and the improvements in QOL of patients with nasopharyngeal carcinoma . To determine if lappaconitine administered prior to radiation therapy reduces the severity of radiation induced oral mucositis pain in patients who have been diagnosed with nasopharyngeal carcinoma.

NCT ID: NCT03221790 Not yet recruiting - Clinical trials for Irritable Bowel Syndrome With Diarrhea

Effect of FODMAPs on Mucosal Inflammation in IBS Patients

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

OBJECTIVE: To gain mechanistic insights, we will compare effects of low fermentable oligosaccharides, disaccharides and monosaccharides and polyols (FODMAP) and high FODMAP diets on symptoms and colonic protease expression in patients with diarrhea predominant irritable bowel syndrome (IBS-D). We will measure how protease changes affect excitability of pain sensing neurons and correlate this with measurements of the metabolome and the microbiome. DESIGN: We aim to perform a single blind prospective study of patients with diarrhea predominant IBS (Rome IV criteria) who will sequentially consume a high and low FODMAP diets, each for 3 weeks. Symptoms will be assessed using the IBS symptom severity scoring (IBS-SSS). Electrophysiological studies of changes in mouse dorsal root ganglia neurons in response to colonic mucosal/lamina propria supernatants will be carried out. Protease antagonist will be used to specifically assess protease expression. The metabolome will be evaluated using metabolic profiling in urine using mass spectrometry. Stool microbiota composition will be analysed by 16S rRNA gene profiling. All the above testing will be performed at 4 time points: at baseline, 3 weeks following a run-in period, after a 3-week-long high FODMAP diet, and after a 3-week-long low FODMAP diet period. HYPOTHESIS: We anticipate that colonic tissue protease effects on the excitability of dorsal root ganglia (DRG) neurons will increase with a high FODMAP diet and decrease with a low FODMAP diet, but that this may not be found in all patients. The magnitude of the effect may vary and this variation could be due to differences in the individual patients microbiome.

NCT ID: NCT03090009 Not yet recruiting - Clinical trials for Peri-implant Mucositis

Microbiome Shift in Peri-mucositis by Anti-inflammatory Drugs

Start date: April 2017
Phase: Early Phase 1
Study type: Interventional

Dental implants are often used to replace missing teeth. In fact, in the US over 700,000 implants are places every year and over 2 million implants are places world wide. Peri-implant mucositis in an inflammatory condition affecting dental implants and is recognized as a risk factor for peri-implantitis (a condition affecting the bone around implants and eventually leading to implant loss). The prevalence of Peri-implant Mucositis has been reported in the literature to range from 50-90% whereas the prevalence of Peri-implantitis has been reported as high as 20%. it is commonly believed that a dysbiotic microbiome is the primary cause for these conditions. The inflammatory burden around diseased implants creates a high-protein environment which is necessary for the survival of pathogenic bacteria. It is logical, therefore, that reducing inflammation by Non Steroidal Anti-Inflammatory Drugs (NSAIDs) may create a shift in the dysbiotic microbiome to a symbiotic microbiome. The aim of the current study is to test the effects of oral NSAIDs on the peri-implant microbiome.

NCT ID: NCT02735317 Not yet recruiting - Clinical trials for Nasopharyngeal Neoplasms

Efficacy and Safety of FORRAD® for the Management of Radiation-induced Mucositis in Patients With Nasopharyngeal Carcinoma Receiving IMRT

Start date: April 2016
Phase: Phase 2
Study type: Interventional

Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). The most frequently occurred radiation-related side effect is probably the radiation-induced oral mucositis (OM), which affects up to 100% of NPC patients receiving radiation therapy. When severe, oral mucositis increases the risk of infection and may compromise clinical outcomes by necessitating treatment breaks, dosage reductions, and reduced therapy compliance. In China, a quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and procaine, is commonly prescribed when NPC patients begin to suffer from radiation-induced OM. However, the incidence of radiation-induced OM is still quite high. Oral Ulcer Gargle (FORRAD®) is a proprietary viscous liquid mucoadhesive hydrogel formulation. It creates a palliative barrier over injured mucosa, to prevent and to cure radiation-induced OM. The objective of this randomized phase II study is to assess the efficacy and safety of Oral Ulcer Gargle (FORRAD®) as an intervention for radiation-induced OM in the treatment of NPC, compared with the commonly used quadruple mixture, which is composed of dexamethasone, gentamicin, vitamin B12, and procaine.

NCT ID: NCT02506231 Not yet recruiting - Clinical trials for Graft vs Host Disease

The Effect of Folinic Acid Rescue Following MTX GVHD Prophylaxis on Regimen Related Toxicity and Transplantation Outcome

Start date: October 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess the impact of folinic acid (FA) -rescue following methotrexate (MTX) graft-versus-host disease (GVHD) prophylaxis on regimen related toxicity and transplantation outcomes after allogeneic hematopoietic cell transplantation (alloHCT) in a double blind randomized controlled trial.

NCT ID: NCT02313792 Not yet recruiting - Mucositis Clinical Trials

Palifermin for Patients Receiving Hematopoietic Stem Cell Transplantation

Start date: January 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of palifermin on reducing mucositis for patients receiving autologous or allogeneic stem cell transplantation with supportive care.

NCT ID: NCT01321307 Not yet recruiting - Mucositis Clinical Trials

Aphtostomatitis and Mucositis Treatment by Natural Herbal Formula (Sorend®)

Start date: April 2011
Phase: N/A
Study type: Observational

Sorend is a water-based formula, which contains carob, melissa and sage. Elder inhabitants of Israel are known to use carob extract to ease sores in the mouth, due to the tannins which create a complex with various proteins and polysaccharides, thus creating an impenetrable layer covering the sores, allowing spontaneous healing.

NCT ID: NCT01087476 Not yet recruiting - Mucositis Clinical Trials

Double-blind-randomized,Placebo Controlled Trial for Chemotherapy-associated Oral Mucositis Using Doxycycline Hyclate

Start date: May 2010
Phase: Phase 2
Study type: Interventional

Background. Mucositis is a complication of chemotherapy with no effective treatment. Aim.To evaluate the efficacy of sub-microbial doses of doxycycline hyclate in preventing the development of oral mucositis in patients with acute leukemia (AL) treated with induction chemotherapy. Hypothesis. Doxycycline hyclate administration in sub-microbial dosage will reduce the incidence of oral mucositis in patients with AL who receive induction chemotherapy. Methods. Double-blind, randomized, placebo-controlled clinical trial. At the Cancer National Institute (INCan), adult patients (> 18 years of age) with acute leukemia of recent diagnosis, scheduled to receive induction chemotherapy will be enrolled in the study. Written informed consent from the patients will be obtained preceding inclusion in the study. At baseline and 3-times per week, during 21-days, patients will have an oral examination performed using the Oral Mucositis Assessment Scale (OMAS), oral pain, difficulty to swallow, and salivary flow measurements will be recorded. A sample size of 164 subjects has been calculated, 74 subjects in each arm of the study. The primary end point of this study to evaluate the efficacy will be the proportion of patients treated with doxycycline or placebo without oral lesions associated with OM, during the 21 days of follow-up. Efficacy will be evaluated if the proportion of complete response (CR) is significantly higher than the proportion of events in the placebo group. Additional secondary endpoints will be the partial resolution of the oral lesions, the incidence of infections and the mortality in the study groups during the 21 days of follow-up. Results will be analyzed by using Chi-squared test and Wilcoxon-Mann-Whitney rank sum test.

NCT ID: NCT00699569 Not yet recruiting - Clinical trials for Head and Neck Cancer

Hyperimmune Colostrum and Oral Mucositis

Mucositis
Start date: July 2008
Phase: N/A
Study type: Interventional

To study the effect of daily intake of hyperimmune colostrum on prevention and treatment of oral mucositis in patients with head and neck cancer undergoing high-dose radiation.