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

Léon Bérard Center

Status and phase: Terminated; Phase 3

Conditions: Oropharynx Cancer; Hypopharynx Cancer

Treatments: Drug: Homeodent®; Drug: 1.4% Sodium Bicarbonate solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01066741

ET2006-042

HOMEODENT

Details and patient eligibility

About

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).

Full description

The standard treatment of oral cavity, oropharynx, hypopharynx, and cavum cancers is external radiotherapy. However, one of the associated toxicities is the occurrence of mucositis which can be a limiting factor in the treatment (dose reduction or treatment interruption can limit patient's survival), patient's quality of life decreases and severe complications can occur. The treatment of mucositis is mainly symptomatic; a randomized study has shown a benefit of a mouthwash with Benzydamine, a non steroidal anti-inflammatory drug, for patients receiving 50-Gy radiation. Another study with a lower number of patients has also shown a benefit of using a zinc sulfate solution. Boiron laboratories have developed a phytopharmaceutical preparation, Homeodent®, which has no secondary effects and which could prevent radiation-induced mucositis. This study will evaluate the efficiency of mouthwash with Homeodent® in a large randomized trial.

Enrollment: 78 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

Homeodent®

Experimental group

Description:

Mouthwash with Homeodent® is started on the first day of irradiation, then continued until the end of the irradiation period or until occurrence of grade ≥3 mucositis. In case of grade ≥3 mucositis, patients are instructed to mouthwash with Sodium Bicarbonate solution until complete disappearance of mucositis or until the end of irradiation.

Treatment:

Drug: Homeodent®

1.4 % Sodium Bicarbonate solution

Active Comparator group

Description:

Mouthwash with sodium bicarbonate is started on the first day of irradiation, then continued until the end of the irradiation period. In case of grade ≥3 mucositis, mouthwash is continued until complete disappearance of the mucositis or until the end of irradiation. In both arms, after the end of irradiation, patients can receive treatment with Sodium Bicarbonate solution until complete disappearance of the mucositis.

Treatment:

Drug: 1.4% Sodium Bicarbonate solution