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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01066741
• Date of registration: 05/02/2010
• Prospective Registration: No
• Primary sponsor: Centre Leon Berard
• Public title: Prevention of Radiation-induced Severe Oral Mucositis in Oral Cavity, Oropharynx, Hypopharynx, and Cavum Cancer
• Scientific title: Randomized Evaluation of a Phytopharmaceutical in Prevention of Severe Oral Mucositis in Patients Receiving Radiotherapy for Oral Cavity, Oropharynx, Hypopharynx, or Cavum Cancer
• Date of first enrolment: May 2009
• Target sample size: 78
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01066741
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Pascal POMMIER
• Affiliation: Centre Léon Bérard, LYON

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hypopharynx Cancer

Oropharynx Cancer

Intervention(s)

Drug: Homeodent®

Drug: 1.4% Sodium Bicarbonate solution

Primary Outcome(s)

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(s)

Rate of Mycosis and Herpes virus infection [Time Frame: 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)]

Evaluation of the cost of severe mucositis treatment [Time Frame: during and until the end of severe mucositis treatment]

Rate and duration of radiation treatment interruption for toxicity [Time Frame: At the end of irradiation period (6 weeks)]

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)]

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]

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]

Rate of grade =2 mucositis [Time Frame: At the end of irradiation period (6 weeks)]

Treatment tolerance assessed through a satisfaction questionnaire, and evaluation of compliance [Time Frame: during medication administration]

Secondary ID(s)

ET2006-042

HOMEODENT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

BOIRON