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.
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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
incidence of grade III/IV mucositis
Evaluation of the grade III and IV mucositis incidence in patients undergoing chemo-radiotherapy and taking CD#2 or standard therapy (bicarbonate sodium mouthwash)
Vitaliana De Sanctis, PhD
Sant'Andrea Hospital - Radiotherapy Unit
Ethics Committee, Italy ':'