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

Phase 3

Completed

• Conditions: Head and Neck Cancer; Oral Mucositis
• Interventions: Drug: SBG; Other: Placebo

• Registration Number: NCT00790322
• Lead Sponsor: Biotec Pharmacon ASA

Brief 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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-11
• Study First Submitted QC: 2008-11-11
• Study First Posted: 2008-11-13
• Status Verified: 2010-02
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2010-02-18
• Last Update Posted: 2010-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	SBG	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Compare the proportion of patients in the two arms who develop severe oral mucositis	During radiation therapy

Trial Locations

Locations (1)

Institute Gustave Roussy; 🇫🇷 Villejuif Cédex, France