Active clinical trials for "Stomatitis"

This purpose of this study is to investigate whether ATL-104 is safe and well tolerated, and whether it shows evidence of efficacy in mucositis in patients undergoing PBSCT

CG53135-05, a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. The objective of this Phase II trial is to evaluate the safety and efficacy of CG53135-05 when administered as a single dose to patients at risk for developing oral mucositis.

This study was designed to investigate the effect of Gum Arabic (GA) on cancer patients to prevent chemotherapy-induced oral mucositis. Cancer patients who will receive chemotherapy were divided into two groups; study "Gum Arabic" group (which received GA with chemotherapy) and control group (chemotherapy alone); and the participants were recruited to reach 190 patients in the study group and 184 patients in control group. This clinical trial was conducted in outpatient chemotherapy sections at Radiation and Isotopes Center of Khartoum. This study was designed to test the theory that say the chemotherapy-induced oral mucositis will significantly decrease after ingestion 30 grams as daily dose of Gum Arabic in a form of solution for six weeks during therapy.

The main aim of this study was to evaluate the effectiveness of melatonin in prevention of radiation induced oral mucositis clinically and biochemically.

Introduction: Traumatic oral lesions are common in the beginning of the orthodontic treatment, and pathogenic oral bacteria might be involved. We tested whether the probiotic Lactobacillus brevis CD2 (L brevis) is benefic in this condition. Methods: In a double-blind clinical trial, 20 patients were randomized to 21 days course of lozenges containing L brevis CD2 (4 billion colony-forming units after breakfast, lunch and dinner) or placebo, starting on the day of installation of the fixed orthodontic appliance. Main outcomes were days without oral lesions and oral pain score [ranging between 0 (no pain) and 10 (maximum)]. Oral health related quality of life was measured by OHIP-14 before and after treatments.

The overall purpose of this study is to examine the efficacy of prophylactic low-level laser therapy (LLLT) to reduce the incidence of oral mucositis and adverse events in patients receiving combined modality therapy consisting of chemotherapy and radiation therapy for head and neck cancer.

Patients with various malignancies who are taken up for high dose chemotherapy followed by stem cell transplant (blood and marrow transplant) have very high chances of developing severe oral mucositis (between 95-100%). This mucositis not only causes significant morbidity but also hampers quality of life so much so that patients at times feel difficult to continue treatment. No definite treatment exists for prevention or treatment of oral mucositis in this group of patients. Though one study has suggested that use of IV palifermin (a keratinocyte growth factor) will reduce duration and severity. Palifermin is very expensive and not available in country. Recently the investigators have shown effectiveness of a probiotic Lactobacillus CD 2 in reducing incidence and severity of chemo-radiotherapy induced mucositis in head and neck squamous cell cancer patients. (Published online in European Journal of Cancer: http://dx.doi.org/10.1016/j.ejca.2011.06.010). No significant toxicity has been reported with its use. Now, the investigators want to study the efficacy of this drug to reduce severity of mucositis in patients undergoing hematopoietic stem cell transplantation. The drug will be supplied by CD Pharma India Private Limited. The investigators further give undertaking that study will be carried as per good clinical practices (GCP) and declaration of Helsinki.

Oral mucositis remains a limiting factor in in head and neck squamous cell carcinomas patients treated with chemoradiation leading to pain, dysphagia, and weight loss. Low-level laser therapy emerges as a promising, preventive therapy of chemoradiation-induced OM. This study was designed to assess the efficacy of Low Level Laser Therapy (LLLT) in reducing the incidence and/or severity of oral mucositis.

CG53135-05 (velafermin), a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. The objective of this Phase II trial is to confirm the safety and efficacy of CG53135-05 (velafermin) when administered as a single dose to patients at risk for developing oral mucositis.

Radiotherapy and high dose chemotherapy with bone marrow transplantation or peripheral blood stem cell transplantation is frequently used as treatment for patients with cancers of the bone marrow or lymph nodes such as Hodgkin's disease, non-Hodgkin's lymphoma, leukemia or multiple myeloma. A common side effect of the radiotherapy and high dose chemotherapy is mucositis (inflammation of the inside of the mouth and throat resulting in pain and difficulty swallowing). Mucositis is often very severe such that patients receive intravenous nutrition and pain medication in the hospital. In this study, an investigational recombinant human growth factor called Keratinocyte Growth Factor (rHuKGF) is being evaluated to determine its protective effect on the mucosal tissue and its ability to reduce the mouth and throat soreness.