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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00790322

Enrollment

130

Registered

2008-11-13

Start date

2008-10-31

Completion date

2010-02-28

Last updated

2010-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Oral Mucositis

Keywords

Cancer, Radiation therapy, Radiotherapy, Oral Mucositis, SBG

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.

Interventions

DRUGSBG

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

OTHERPlacebo

Solution for oral use

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026