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Oral Mucositis clinical trials

View clinical trials related to Oral Mucositis.

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NCT ID: NCT01668849 Completed - Clinical trials for Head and Neck Cancer

Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer

Start date: August 2, 2012
Phase: Phase 1
Study type: Interventional

This study will evaluate the ability of grape exosomes, given to the subject as grape powder, as an important anti-inflammatory agent to reduce the incidence of oral mucositis during radiation and chemotherapy treatment for head and neck tumors.

NCT ID: NCT01480011 Completed - Oral Mucositis Clinical Trials

A Pilot Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation

Start date: November 2011
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT01431729 Completed - Oral Mucositis Clinical Trials

Honey and a Mixture of Honey, Beeswax and Olive Oil-propolis Extract in Treatment of Chemotherapy-induced Oral Mucositis

Start date: June 2010
Phase: Phase 2
Study type: Observational

Although, oral mucositis has been studied for many years, no available treatment has been shown to be effective in preventing or treating mucositis. Based on the observations that honey and other products of honeybees have anti-inflammatory, anti-oxidant, anti-microbial and wound healing effects, the present study aims at evaluation of the effect of topical application of honey and a mixture of honey, beeswax and olive oil-propolis extract, as natural products, in treatment of chemotherapy-induced oral mucositis in children with acute lymphoblastic leukemia (ALL). This is a randomised controlled clinical trial in which eligible patients were randomly assigned into three equal treatment groups. Group 1 received 15 gm honey applied topically to the affected oral mucosa three times daily. Group 2 received 5 gm of a mixture of honey, olive oil-propolis extract and bees wax (HOPE) applied topically to the oral mucosa three times daily. Group 3 served as control and received a 7.5% benzocaine gel applied to the areas of ulcers three times daily.

NCT ID: NCT01400620 Completed - Oral Mucositis Clinical Trials

Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer

Start date: March 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether an oral rinse composed of botanical extracts is effective in the prevention of severe inflammation of the lining of the oral cavity caused by chemotherapy and radiation therapy for head and neck cancer.

NCT ID: NCT01385748 Completed - Oral Mucositis Clinical Trials

Efficacy and Safety Study of Clonidine Lauriad® to Treat Oral Mucositis

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

The purpose of this study is to evaluate the efficacy and safety of Clonidine Lauriad® to treat chemoradiation therapy induced severe oral mucositis in patients with head and neck cancer.

NCT ID: NCT01307540 Completed - Oral Mucositis Clinical Trials

Phototherapy for the Management of Oral Ulcers in Bone Marrow Recipients

Start date: February 2007
Phase: N/A
Study type: Interventional

Study hypothesis: light therapy may prevent oral ulcers in bone marrow recipients. Methods: patients will be treated with either active light-emitting device or inactive light-emitting device. Daily treatment with light therapy will start at the beginning of the conditioning regimen and will last until day 21 post-transplant. Each daily treatment last about 5 minutes. Patients will be evaluated for oral mucositis and oral pain level on a weekly basis.

NCT ID: NCT01283906 Completed - Oral Mucositis Clinical Trials

A Study to Evaluate the Efficacy of MuGard for the Amelioration of Oral Mucositis in Head and Neck Cancer Patients

MuGard
Start date: January 2011
Phase: Phase 4
Study type: Interventional

This study is a randomized, double-blind, sham-controlled, two-arm study conducted in subjects receiving chemoradiation therapy for the treatment of head and neck cancer to assess the efficacy of MuGard. The study will evaluate the ability of MuGard to reduce the symptoms of oral mucositis. The study includes a treatment period of approximately 7 weeks depending on the subject's prescribed radiation plan. MuGard is a liquid that is classified as a medical device. It is a hydrated polymer system (oral hydrogel) and is intended for the management of oral mucositis/stomatitis. When gently distributed within the mouth, the mucoadhesive formulation results in the formation of a protective coating over the oral mucosa. Subjects undergoing chemotherapy with radiation for the treatment of head and neck cancer are at high risk of developing oral mucositis as an adverse side-effect of cancer treatment. MuGard was previously shown to reduce the incidence and severity of mucositis in head and neck cancer patients undergoing radiation therapy when compared with data from historical control groups. The purpose of this study is to perform a direct comparison of the effectiveness of MuGard with a control group.

NCT ID: NCT01163097 Completed - Oral Mucositis Clinical Trials

Study to Characterize the Effect of Heparin on Palifermin Activity

Start date: July 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of a continuous intravenous infusion of unfractionated heparin on the multiple-dose pharmacodynamics of palifermin in healthy adult subjects.

NCT ID: NCT01115049 Completed - Oral Mucositis Clinical Trials

Hexetidine and Chlorobutanol for Lesions Due to Prostheses

Start date: February 2010
Phase: Phase 4
Study type: Interventional

Objectives: The study aimed at assessing the efficacy of a new mouthwash in treating oral lesions due to removable prostheses. Methods: The present prospective randomized clinical trial was performed on 44 patients. The experimentation lasted for 4 weeks and 4 operators participated. The effects of the mouthwash were evaluated subjectively and objectively, with questionnaires, Visual Analogic Scales and clinical examinations. The results were statistically analyzed. The following variables were recorded: presence of mucosal lesions due to incongruous removable prostheses and lasting of pain after rinsing.

NCT ID: NCT01083875 Completed - Oral Mucositis Clinical Trials

Study to Determine the Effects Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region

Start date: February 2000
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine the effect of 0.5% amlexanox oral rinse compared to a vehicle control on mucositis-related ulceration and erythema (objective score)and on mucositis-related oral pain (subjective score). A secondary objective was to evaluate the safety of 0.5% amlexanox oral rinse by determining the frequency of treatment-emergent drug-related adverse events or clinical laboratory abnormalities.