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Completed

NCT Number: NCT00790322

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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Oral Mucositis Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute Gustave Roussy

Villejuif Cédex, 94805, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

SBG

Drug

Soluble beta-1,3/1,6-glucan is a solution for oral use

Placebo

Other

Solution for oral use

Primary outcomes

  1. Compare the proportion of patients in the two arms who develop severe oral mucositis

    Time frame: During radiation therapy

Sponsors and collaborators

Lead sponsor

Biotec Pharmacon ASA

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 13, 2008
Registry last updated
Feb 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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