The Protective Effect of Soluble Beta-1,3/1,6-Glucan Compared to Placebo in Oral Mucositis in Head and Neck Cancer Patients
The purpose of this study is to explore the protective effect and safety of soluble beta-1,3/1,6-glucan compared to placebo in oral mucositis in head and neck patients receiving radiotherapy or chemoradiotherapy.
Hypothesis: Soluble beta-1,3/1,6-glucan will through its immunomodulating activities prevent oral mucositis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- 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.
- To assess proportions of patients avoiding grade 2 or higher oral mucositis after treatment with soluble beta-1,3/1,6-glucan or placebo
- To assess time before first sign of oral mucositis
- To evaluate impact of toxicities like patients' pain and swallowing difficulty
- To assess the safety of the investigational product
|Study Start Date:||October 2003|
|Estimated Study Completion Date:||July 2006|
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.
|Medical Centre Bonn, Clinic for Radiotherapy and Radiological Oncology|
|Bonn, Germany, 53119|
|Düsseldorf, Germany, 40217|
|Royal Marsden Hospital, Head and Neck Unit|
|London, United Kingdom, SW3 6JJ|
|Principal Investigator:||Christopher M Nutting, Dr.med.||Royal Marsden NHS Foundation Trust|