Severe Acute Mucositis, Head and Neck Cancer
Conditions
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.
Interventions
DIETARY_SUPPLEMENTOral Impact
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.
DIETARY_SUPPLEMENTPlacebo
The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.
Sponsors
GORTEC
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of grade 3 and 4 acute mucosal toxicity | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
France
Outcome results
None listed