NCT00790322

Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Biotec Pharmacon ASA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of SBG vs placebo on oral mucositis in head and neck cancer patients undergoing radiation therapy.

Detailed description

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.

Conditions

• Head and Neck Cancer
• Oral Mucositis

Interventions

Type	Name	Description
DRUG	SBG	Soluble beta-1,3/1,6-glucan is a solution for oral use
OTHER	Placebo	Solution for oral use

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2008-11-13
• Last updated: 2010-02-19

Locations

1 site across 1 country: France