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:
Participant gender:
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).