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

This study has been terminated.
(insufficient recruitment, the planed sample size appears not achievable)
Sponsor:
Collaborator:
BOIRON
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01066741
First received: February 5, 2010
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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).


Condition Intervention Phase
Oropharynx Cancer
Hypopharynx Cancer
Drug: Homeodent®
Drug: 1.4% Sodium Bicarbonate solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of grade ≥2 mucositis [ Time Frame: At the end of irradiation period (6 weeks) ] [ Designated as safety issue: No ]
  • Rate of Mycosis and Herpes virus infection [ Time Frame: At the end of irradiation period (6 weeks) ] [ Designated as safety issue: No ]
  • Rate of use of symptomatic treatment in case of occurrence of mucositis [ Time Frame: At the end of irradiation period (6 weeks) ] [ Designated as safety issue: No ]
  • Rate and duration of radiation treatment interruption for toxicity [ Time Frame: At the end of irradiation period (6 weeks) ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Treatment tolerance assessed through a satisfaction questionnaire, and evaluation of compliance [ Time Frame: during medication administration ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Evaluation of the cost of severe mucositis treatment [ Time Frame: during and until the end of severe mucositis treatment ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: May 2009
Study Completion Date: August 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066741

Locations
France
Centre Léon Bérard
Lyon, France
Sponsors and Collaborators
Centre Leon Berard
BOIRON
Investigators
Principal Investigator: Pascal POMMIER Centre Léon Bérard, LYON
  More Information

Publications:

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01066741     History of Changes
Other Study ID Numbers: HOMEODENT, ET2006-042
Study First Received: February 5, 2010
Last Updated: October 31, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Leon Berard:
Epidermoid carcinoma
Hypopharynx
Oropharynx
Oral cavity
Oral mucosa
Cavum
Severe Oral mucositis
Radiotherapy
Phytotherapy

Additional relevant MeSH terms:
Mucositis
Stomatitis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Mouth Diseases
Stomatognathic Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014