Prevention of Radiation-induced Severe Oral Mucositis in Oral Cavity, Oropharynx, Hypopharynx, and Cavum Cancer
Oropharynx Cancer, Hypopharynx Cancer
About this trial
This is an interventional prevention trial for Oropharynx Cancer focused on measuring Epidermoid carcinoma, Hypopharynx, Oropharynx, Oral cavity, Oral mucosa, Cavum, Severe Oral mucositis, Radiotherapy, Phytotherapy
Eligibility 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
Sites / Locations
- Centre Léon Bérard
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Homeodent®
1.4 % Sodium Bicarbonate solution
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.
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.