TerminatedPhase 3

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

Stopped: insufficient recruitment, the planed sample size appears not achievable

France78 participantsStarted 2009-05

Plain-language 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).

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rate of occurrence of grade ≥ 3 (RTOG classification) mucositis during irradiation (only the first occurrence will be reported)

Timeframe: At the end of irradiation period (6 weeks)

Trial details

NCT IDNCT01066741

SponsorCentre Leon Berard

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-02