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

Primary Purpose

Oropharynx Cancer, Hypopharynx Cancer

Status

Terminated

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Homeodent®

1.4% Sodium Bicarbonate solution

About this trial

This is an interventional prevention trial for Oropharynx Cancer focused on measuring Epidermoid carcinoma, Hypopharynx, Oropharynx, Oral cavity, Oral mucosa, Cavum, Severe Oral mucositis, Radiotherapy, Phytotherapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre Léon Bérard

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Homeodent®

1.4 % Sodium Bicarbonate solution

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of grade ≥2 mucositis

Rate of Mycosis and Herpes virus infection

Rate of use of symptomatic treatment in case of occurrence of mucositis

Rate and duration of radiation treatment interruption for toxicity

radiation dose, duration of grade ≥3 mucositis, maximum weight loss and maximum level of oral pain in case of grade ≥3 mucositis.

Treatment tolerance assessed through a satisfaction questionnaire, and evaluation of compliance

Nutritional intake, estimated using caloric intake and the Detsky score, and rate of enteral and/or parenteral nutrition, in case of toxicity during irradiation

Rate of agreement between the radiation oncologist and the stomatologist for the detection of Grade ≥2 (RTOG classification) mucositis

Evaluation of the cost of severe mucositis treatment

Full Information

NCT ID

NCT01066741

First Posted

February 5, 2010

Last Updated

October 31, 2012

Sponsor

Centre Leon Berard

Collaborators

BOIRON

1. Study Identification

Unique Protocol Identification Number

NCT01066741

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Terminated

Why Stopped

insufficient recruitment, the planed sample size appears not achievable

Study Start Date

May 2009 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Leon Berard

Collaborators

BOIRON

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oropharynx Cancer, Hypopharynx Cancer

Keywords

Epidermoid carcinoma, Hypopharynx, Oropharynx, Oral cavity, Oral mucosa, Cavum, Severe Oral mucositis, Radiotherapy, Phytotherapy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Homeodent®

Arm Type

Experimental

Arm Description

Arm Title

1.4 % Sodium Bicarbonate solution

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Homeodent®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

1.4% Sodium Bicarbonate solution

Intervention Description

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

Primary Outcome Measure Information:

Title

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)

Secondary Outcome Measure Information:

Title

Rate of grade ≥2 mucositis

Time Frame

At the end of irradiation period (6 weeks)

Title

Rate of Mycosis and Herpes virus infection

Time Frame

At the end of irradiation period (6 weeks)

Title

Rate of use of symptomatic treatment in case of occurrence of mucositis

Time Frame

At the end of irradiation period (6 weeks)

Title

Rate and duration of radiation treatment interruption for toxicity

Time Frame

At the end of irradiation period (6 weeks)

Title

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

Title

Treatment tolerance assessed through a satisfaction questionnaire, and evaluation of compliance

Time Frame

during medication administration

Title

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

Title

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)

Title

Evaluation of the cost of severe mucositis treatment

Time Frame

during and until the end of severe mucositis treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pascal POMMIER

Organizational Affiliation

Centre Léon Bérard, LYON

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Léon Bérard

City

Lyon

Country

France

12. IPD Sharing Statement

Citations:

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Citation

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Citation

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

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