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

October 31, 2012 updated by: Centre Leon Berard

Randomized Evaluation of a Phytopharmaceutical in Prevention of Severe Oral Mucositis in Patients Receiving Radiotherapy for Oral Cavity, Oropharynx, Hypopharynx, or Cavum Cancer

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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 Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France
        • Centre Leon Berard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Homeodent®
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.
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.
Active Comparator: 1.4 % Sodium Bicarbonate solution

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.
Drug: 1.4% Sodium Bicarbonate solution
Two-minute mouthwash with 125 ml of solution, 3 times per day after meals and tooth brushing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
At the end of irradiation period (6 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of grade ≥2 mucositis
Time Frame: At the end of irradiation period (6 weeks)
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)
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)
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)
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
during the occurence of grade≥3 mucositis
Treatment tolerance assessed through a satisfaction questionnaire, and evaluation of compliance
Time Frame: during medication administration
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
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)
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
during and until the end of severe mucositis treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Collaborators

BOIRON

Investigators

  • Principal Investigator: Pascal POMMIER, Centre Léon Bérard, Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

February 5, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (Estimate)

February 10, 2010

Study Record Updates

Last Update Posted (Estimate)

November 1, 2012

Last Update Submitted That Met QC Criteria

October 31, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOMEODENT
  • ET2006-042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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