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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
160
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.
The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.
Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, France
The rate of grade 3 and 4 acute mucosal toxicity
Time frame: 3 months
Tolerance
tolerance of treatment with the CTCAE (Common Terminology Criteria for Adverse Events)
Time frame: through study completion, an average of 3 years
compliance to the oral immunomodulating formula
Time frame: through study completion, an average of 3 years
overall quality of life (EORTC QLQ-C30 Questionnaire)
Time frame: through study completion, an average of 3 years
progression-free survival rates
Time frame: 1, 2 and 3 years
overall survival rates
Time frame: 1, 2 and 3 years
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