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

Study Overview
=================
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.

Official Title
-----------------
Phase III Multicenter, Randomised and Double-blind Study Comparing an Oral Immunomodulatory Solution Versus a Placebo in Preventing Severe Acute Mucositis in Head and Neck Cancer Patients Treated Surgically and Concomitantly With Radiochemotherapy

Conditions
-----------------
Severe Acute Mucositis, Head and Neck Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: Oral Impact
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral immunomodulatory solution<br>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. | Dietary Supplement: Oral Impact<br>* The patients will benefit in each case from a similar energy supplement (either Oral Impact or placebo) during the 5 days preceding the course of chemotherapy. They will receive the supplement 3 times per day at 10am, 3pm and 5pm outside of their meals. In total, the patients will take the supplements for 15 days (3 courses of 5 days). If the patient has difficulty taking the treatment orally, it can be given via an enteral tube (nasogastric tube or percutaneous gastrostomy). All patients in the protocol will systematically receive a dietetic consultation. This consultation by a dietician will detect malnutrition and result in nutritional counsel if necessary (advice re. enrichment of diet, CNO without immunonutrients, artificial nutrition). Follow-up appointments with a dietician will be organised every 3 weeks to maintain adherence to the suggested dietary changes.<br>|
| Placebo Comparator: Placebo<br>The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients. | Dietary Supplement: Placebo<br>* The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of grade 3 and 4 acute mucosal toxicity |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance | tolerance of treatment with the CTCAE (Common Terminology Criteria for Adverse Events) | through study completion, an average of 3 years | 
| 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 |