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

NCT01066741 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2012-11-01

No results posted yet for this study

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).

Conditions

  • Oropharynx Cancer
  • Hypopharynx Cancer

Interventions

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

Sponsors & Collaborators

  • BOIRON

    collaborator INDUSTRY

  • Centre Leon Berard

    lead OTHER

Principal Investigators

  • Pascal POMMIER · Centre Léon Bérard, Lyon

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-02-28
Completion
2011-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01066741 on ClinicalTrials.gov