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NCT00790322 Clinical Trial

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

Head and Neck Cancer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00790322
Other study ID # SBG-2-03
Secondary ID EudraCT-number:
Status Completed
Phase Phase 3
First received November 11, 2008
Last updated February 18, 2010
Start date October 2008
Est. completion date February 2010

Study information
Verified date February 2010
Source Biotec Pharmacon ASA
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility - Patients with a normal oral mucosa who is scheduled to receive radiation therapy for their head and neck cancer will be enrolled into the study.

- Patients with previous head and neck cancer and/or radiation therapy in the head and neck area and history/clinical evidence of active significant acute or chronic conditions that may compromise the ability to evaluate or interpret the effects of the study treatment on mucositis will be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• SBG
Soluble beta-1,3/1,6-glucan is a solution for oral use
Other:
• Placebo
Solution for oral use

Locations
Country Name City State
France Institute Gustave Roussy Villejuif Cédex

Sponsors (1)
Lead Sponsor Collaborator
Biotec Pharmacon ASA

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compare the proportion of patients in the two arms who develop severe oral mucositis During radiation therapy No
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