Randomized Evaluation of a Phytopharmaceutical in Prevention of Severe Oral Mucositis in Patients Receiving Radiotherapy for Oral Cavity, Oropharynx, Hypopharynx, or Cavum Cancer
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Rate of occurrence of grade ≥ 3 (RTOG classification) mucositis during irradiation (only the first occurrence will be reported)
At the end of irradiation period (6 weeks)
No
Pascal POMMIER
Principal Investigator
Centre Léon Bérard, LYON
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
HOMEODENT
NCT01066741
May 2009
August 2011
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