Prevention of Radiation-induced Severe Oral Mucositis in Oral Cavity, Oropharynx, Hypopharynx, and Cavum Cancer

• Status: Terminated
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the benefit of a mouthwash with a phytopharmaceutical preparation, Homeodent®, compared to a mouthwash solution containing sodium bicarbonate, for prevention of severe mucositis (grade ≥3, RTOG classification) in patients receiving irradiation for oral cavity, oropharynx, hypopharynx or cavum cancer.

This is a phase III, controlled, randomized, single blind study. The estimated inclusion period is approximately 24 months. The number of patients required in this monocentric study is 330 (165 per arm).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Leon Berard
• Collaborator: BOIRON
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Male or female patient aged ≥ 18 years

• ECOG PS ≤ 2

• Patient with oral cavity and/or oropharynx and/or hypopharynx and/or cavum epidermoid carcinoma, whatever the stage

• Patient receiving a minimum radiation dose of 60 Gy

• Planned radiotherapy to at least 1/3 of the oral mucosa and/or oropharynx

• Mandatory affiliation with a health insurance system

• Signed, written informed consent

Exclusion Criteria:

• Previous irradiation to the oral mucosa and/or oropharynx

• Pre-existing mucositis

• Pregnant or lactating woman (negative serum or urinary pregnancy test for women with child-bearing potential)

• Patient included in another study including experimental radiotherapy possibly toxic to the mucosa

• difficult follow up of the patient

• patient deprived of civil rights