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

Institut du Cancer de Montpellier - Val d'Aurelle

Status: Completed

Conditions: Severe Acute Mucositis; Head and Neck Cancer

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Oral Impact

Study type: Interventional

Funder types: Other

Identifiers

NCT01149642

VA2009/13 (Other Identifier)

IMPATOX

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Oral immunomodulatory solution

Experimental group

Description:

The oral supplement is a 74g sachet containing 302 kcal and 16.7g proteins as well as immunonutrients such as L-Arginine, ARN and omega-3.

Treatment:

Dietary Supplement: Oral Impact

Placebo

Placebo Comparator group

Description:

The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.

Treatment:

Dietary Supplement: Placebo