Randomised Study of Mucositis Prevention After Radiochemotherapy Treatment for Head and Neck Cancer

Not Applicable

Completed

• Conditions: Head and Neck Cancer; Severe Acute Mucositis

• Registration Number: NCT01149642
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

Brief Summary

This randomised, double-blind study will compare an oral immunomodulatory solution to a placebo for the prevention of acute severe mucositis in head and neck cancer patients treated surgically and concomitantly with radiochemotherapy. The investigators expect a decrease of 25% of severe acute mucositis in experimental arm.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-06-22
• Study First Submitted QC: 2010-06-22
• Study First Posted: 2010-06-23
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2018-12
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Epidermal carcinoma proven histologically of the sphere ORL (all locations except nasopharynx).
• Patients with tumours of the oral cavity, the oropharynx, the hypopharynx and the larynx treated initially by surgery and eligible for post-operative radio- chemotherapy concomitantly.

NB. The patients with tumours of the larynx or hypopharynx are eligible if the radiotherapy to the oropharyngeal mucosa will be at least 54 Gy and the mucositis can be visualised without the use of instruments.

• Radio-chemotherapy to be given postoperatively.
• Maximum delay of 8 weeks between the operative date and the planned starting date of radio-chemotherapy.
• Performance status (grade OMS): 0, 1, 2
• Nutritional Risk Index ≥ 83.5
• No mucositis.
• Age: 18-75 years
• Life expectancy ≥ 3 months.
• Informed consent obtained from the patient.
• Affiliation with a social security system.

Exclusion Criteria

• Tumour of nasopharynx
• Mucositis
• Severe sepsis
• Treatment by immunomodulators in the month preceding inclusion
• ATCD allergy to the components of Oral Impact.
• Parenteral nutrition at inclusion
• Usual contraindications to concomitant radio-chemotherapy
• Patient already included in another therapeutic trial involving an experimental molecule
• Female pregnant or susceptible to being pregnant, or breast-feeding. Patient not using appropriate contraceptive measures during the treatment
• Persons deprived of liberty or under guardianship
• Patients unable to commit to the trial schedule for geographical, social or psychological reasons.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The rate of grade 3 and 4 acute mucosal toxicity	3 months

Secondary Outcome Measures

Name	Time	Method
Tolerance	through study completion, an average of 3 years	tolerance of treatment with the CTCAE (Common Terminology Criteria for Adverse Events)
compliance to the oral immunomodulating formula	through study completion, an average of 3 years
overall quality of life (EORTC QLQ-C30 Questionnaire)	through study completion, an average of 3 years
progression-free survival rates	1, 2 and 3 years
overall survival rates	1, 2 and 3 years

Trial Locations

Locations (1)

Institut du Cancer de Montpellier - Val d'Aurelle; 🇫🇷 Montpellier, France