INEC Study: Immuno-modulating Enteral Nutrition in Cancer

The aim of this study is to investigate if enteral immunonutrition of head and neck or esophageal cancer patients, using an arginine, omega 3 fatty acid, nucleotides-enhanced diet \[Impact (R), Novartis\] versus a standard enteral nutrition (control, Novartis), could improve clinical outcomes (mucositis frequency, treatment tolerance), nutritional and immune status, and life quality parameters.

Inclusion Criteria: * H\&N and esophageal cancer patients, not treated by surgery and needing chemoradiotherapy * Performance status: Objective Mucositis Score (OMS) of 0, 1, 2 or Karnofsky \> 50% * Acceptance of a gastrostomy, jejunostomy or a nasogastric tube to conduct enteral nutrition * Informed consent form signed Exclusion Criteria: * H\&N cancer treated by exclusive radiotherapy * H\&N and esophageal cancer which can be treated by exclusive surgery * Tonsil cancer * Existence of metastases * Concomitant cancer * Repeat of cancer at site * Insulin dependant diabetes * Thyroid diseases * Subjects with major surgery or severe infectious status in the 3 preceding months * Biological assessment incompatible with the esophagus chemotherapy treatment (polynuclear cells \< 1500/ml; blood platelets \< 100000/ml; serum creatinine \> 130 µmol/ml; ASAT, ALAT, ALP and bilirubin \> twice the norm) * Patients taking food or supplements enriched with omega 3 (arginine and nucleotides), during the period of the study and in the preceding month * Breast feeding women or in period of fertility without effective means of contraception * Patients who refuse to participate or are unable to receive information or are unable to sign written informed consent.