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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
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
February 5, 2010
Last Updated
October 31, 2012
Sponsor
Centre Leon Berard
Collaborators
BOIRON
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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
No

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
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.
Arm Title
1.4 % Sodium Bicarbonate solution
Arm Type
Active Comparator
Arm Description
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.
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
No
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

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

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