Prevention of Radiation-induced Severe Oral Mucositis in Oral Cavity, Oropharynx, Hypopharynx, and Cavum Cancer
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).
|Oropharynx Cancer Hypopharynx Cancer||Drug: Homeodent® Drug: 1.4% Sodium Bicarbonate solution||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||Randomized Evaluation of a Phytopharmaceutical in Prevention of Severe Oral Mucositis in Patients Receiving Radiotherapy for Oral Cavity, Oropharynx, Hypopharynx, or Cavum Cancer|
- Rate of occurrence of grade ≥ 3 (RTOG classification) mucositis during irradiation (only the first occurrence will be reported) [ Time Frame: At the end of irradiation period (6 weeks) ]
- Rate of grade ≥2 mucositis [ Time Frame: At the end of irradiation period (6 weeks) ]
- Rate of Mycosis and Herpes virus infection [ Time Frame: At the end of irradiation period (6 weeks) ]
- Rate of use of symptomatic treatment in case of occurrence of mucositis [ Time Frame: At the end of irradiation period (6 weeks) ]
- Rate and duration of radiation treatment interruption for toxicity [ Time Frame: At the end of irradiation period (6 weeks) ]
- radiation dose, duration of grade ≥3 mucositis, maximum weight loss and maximum level of oral pain in case of grade ≥3 mucositis. [ Time Frame: during the occurence of grade≥3 mucositis ]
- Treatment tolerance assessed through a satisfaction questionnaire, and evaluation of compliance [ Time Frame: during medication administration ]
- Nutritional intake, estimated using caloric intake and the Detsky score, and rate of enteral and/or parenteral nutrition, in case of toxicity during irradiation [ Time Frame: during the period of toxicity ]
- Rate of agreement between the radiation oncologist and the stomatologist for the detection of Grade ≥2 (RTOG classification) mucositis [ Time Frame: At the end of irradiation period (6 weeks) ]
- Evaluation of the cost of severe mucositis treatment [ Time Frame: during and until the end of severe mucositis treatment ]
|Study Start Date:||May 2009|
|Study Completion Date:||August 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
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.
Two-minute mouthwash with 5 ml of solution diluted in 125 ml of water, 3 times per day after meals and tooth brushing.
Active Comparator: 1.4 % Sodium Bicarbonate solution
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.
Drug: 1.4% Sodium Bicarbonate solution
Two-minute mouthwash with 125 ml of solution, 3 times per day after meals and tooth brushing
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066741
|Centre Léon Bérard|
|Principal Investigator:||Pascal POMMIER||Centre Léon Bérard, LYON|