Title

Prevention of Radiation-induced Severe Oral Mucositis in Oral Cavity, Oropharynx, Hypopharynx, and Cavum Cancer
Randomized Evaluation of a Phytopharmaceutical in Prevention of Severe Oral Mucositis in Patients Receiving Radiotherapy for Oral Cavity, Oropharynx, Hypopharynx, or Cavum Cancer
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Status

    Terminated
  • Intervention/Treatment

    sodium bicarbonate ...
  • Study Participants

    78
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).
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.
Study Started
May 31
2009
Primary Completion
Feb 28
2011
Study Completion
Aug 31
2011
Last Update
Nov 01
2012
Estimate

Drug Homeodent®

Two-minute mouthwash with 5 ml of solution diluted in 125 ml of water, 3 times per day after meals and tooth brushing.

Drug 1.4% Sodium Bicarbonate solution

Two-minute mouthwash with 125 ml of solution, 3 times per day after meals and tooth brushing

Homeodent® Experimental

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.

1.4 % Sodium Bicarbonate solution Active Comparator

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.

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
No Results Posted