INEC Study: Immuno-modulating Enteral Nutrition in Cancer

University Hospital, Clermont-Ferrand

Status and phase

Completed

Phase 4

Conditions

Esophageal Cancer

Malnutrition

Head and Neck Cancer

Treatments

Dietary Supplement: Impact (R) Enteral Nutrition

Other: impact

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00333099

CHU63-0012

Details and patient eligibility

About

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.

Full description

Malnutrition is frequent in head and neck (H&N) and esophageal cancers and alters immune status, anti-infectious and anti-tumoral defenses and the response to the treatment (surgery, chemotherapy, radiotherapy). Treatment of these 2 types of cancer is often chemoradiotherapy which frequently induces mucositis. Mucositis enhances nutritional risk and could impose a modification or an interruption of the treatment. 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.

Enrollment

250 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.