A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Assess the Efficacy and Safety of SBG on Oral Mucositis in Head and Neck Cancer Patients Undergoing Radiation Therapy With or Without Chemotherapy
The objective of the study is to evaluate the efficacy and safety of soluble
beta-1,3/1,6-glucan (SBG) on oral mucositis compared to placebo in head and neck cancer
patients undergoing radiation therapy with or without chemotherapy.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Compare the proportion of patients in the two arms who develop severe oral mucositis
During radiation therapy
Germany: Federal Institute for Drugs and Medical Devices