Effect of Lactobacillus Brevis CD2 in Prevention of Radio-chemotherapy Induced Oral Mucositis in Head and Neck Cancer
|Mucositis||Dietary Supplement: CD#2 Other: bicarbonate sodium mouthwash||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Randomized Study on the Effects of Lactobacillus Brevis CD2 in the Prevention of Radio and Chemotherapy Induced Oral Mucositis in Head and Neck Cancer Patients.|
- incidence of grade III/IV mucositis [ Time Frame: 2 months ]Evaluation of the grade III and IV mucositis incidence in patients undergoing chemo-radiotherapy and taking CD#2 or standard therapy (bicarbonate sodium mouthwash)
- percentage of patients able to complete the chemo-radiotherapy treatment [ Time Frame: 2 months ]
- percentage of patients who need enteral nutrition [ Time Frame: 2 months from enrolment ]
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: CD#2
patients will be asked to melt slowly in the mouth 6 lozenges per day, containing Lactobacillus brevis CD2
Dietary Supplement: CD#2
patient will be asked to take 6 lozenges every day and let it dissolve slowly in the mouth
Other Name: Lozenge containing Lactobacillus brevis CD2
Active Comparator: bicarbonate sodium mouthwash
patients will be asked to wash their mouth with bicarbonate several times per day
Other: bicarbonate sodium mouthwash
Patients will be asked to wash their mouth with bicarbonate sodium several times per day
Mucositis is a debilitating side effect of radio and chemotherapy treatment in oncology patients. It is not only painful, but also can limit adequate nutritional intake and decrease the willingness of patients to continue the treatment. Furthermore, extensive mucositis may require additional nutritional supplementation, and narcotic analgesic increasing the cost of the therapy. Quality of life is impaired in patients who develop severe mucositis.
Clinically, it begins with asymptomatic redness and erythema and ultimately passing through different stages to large acutely painful contiguous pseudomembranous lesions with associated dysphagia and decreased oral intake. The common sites of oral mucositis are labial, buccal, soft palate, floor of mouth, and the ventral surface of the tongue. The loss of the epithelial cells exposes the underlying connective tissue with its associated innervations causing pain. Oral infections, which may be due to bacterial, fungal, or viruses may further exacerbate the mucositis as well as lead to systemic infections.
Treatment and prevention of therapy related mucositis is essential; unfortunately, the efficacy and safety of most of the regimen used have not been clearly established. Prophylactic measures employed are use of: chlorhexidine, saline rinses, soda bicarbonate rinses, acyclovir, and ice. For treatment of mucositis and its associated pain local anesthetic, diphenhydramine, nystatin, or sucralfate are used alone or in combination as mouthwash. Oral or parenteral narcotics are also used for pain relief.
There is a clear need for new therapeutic options for oral mucositis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707641
|Contact: Vitaliana De Sanctis, PhDemail@example.com|
|Rome, Italy, 00189|
|Contact: Vitaliana De Sanctis, PhD firstname.lastname@example.org|
|Principal Investigator: Vitaliana De Sanctis, PhD|
|Principal Investigator:||Vitaliana De Sanctis, PhD||Sant'Andrea Hospital - Radiotherapy Unit|