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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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).


Detailed Summary: 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.
Sponsor: Centre Leon Berard

Current Primary Outcome: 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) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Centre Leon Berard

Dates:
Date Received: February 5, 2010
Date Started: May 2009
Date Completion:
Last Updated: October 31, 2012
Last Verified: October 2012