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INEC Study: Immuno-modulating Enteral Nutrition in Cancer

CompletedPhase 4

Sponsor: University Hospital, Clermont-Ferrand

Conditions: Malnutrition, Esophageal Cancer, Head and Neck Cancer

Interventions: Impact (R) Enteral Nutrition, impact

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Clermont-Ferrand, Auvergne, France