An Exploratory, Randomised, Parallel Group Study, Comparing the Protective Effect of Soluble Beta-1,3/1,6-Glucan or Placebo in Oral Mucositis in Head and Neck Cancer Patients Receiving Radiation Therapy or Chemoradiotherapy
Oral mucositis is defined as inflammation and ulceration of the mucous membranes of the
mouth. The condition is very painful and might put the patient at risk of serious systemic
infections and is a common dose-limiting toxicity of chemotherapy and radiotherapy. The
present treatment of mucositis is primarily supportive; strong analgesics in addition to
oral hygiene. Prophylactic antibiotics have been used and many topical agents are available
to palliate mucositis, but no standard therapy has been accepted.
Comparison: Methyl cellulose has been chosen as placebo due to its close resemblance to
soluble beta-1,3/1,6-glucan in terms of general appearance and viscosity. Methyl cellulose
is a viscous solution which might form a mucosal barrier. Physical barriers are considered
having a protective function in oral mucositis, and methyl cellulose might be considered as
an active control.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
To assess actual grade of mucositis upon completion of radiotherapy or chemoradiotherapy and after prophylactic treatment with soluble beta-1,3/1,6-glucan or placebo.
Christopher M Nutting, Dr.med.
Royal Marsden NHS Foundation Trust
United Kingdom: Medicines and Healthcare Products Regulatory Agency