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

Biotec Pharmacon ASA130 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

130

Conditions

Head and Neck Cancer Oral Mucositis

Interventions

SBGDRUG

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

PlaceboOTHER

Solution for oral use

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* 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.

Locations (1)

Institute Gustave Roussy

Villejuif Cédex, France

Outcomes

Primary Outcomes

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

Time frame: During radiation therapy

Data from ClinicalTrials.gov

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