INEC Study: Immuno-modulating Enteral Nutrition in Cancer

University Hospital, Clermont-Ferrand250 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

250

Conditions

Malnutrition Esophageal Cancer Head and Neck Cancer

Interventions

Impact (R) Enteral NutritionDIETARY_SUPPLEMENT

mucositis frequency, treatment tolerance

impactOTHER

1500 calories every day : -5 days before the begining of the chemoradiotherapy and until the last day of the treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Hotel Dieu

Clermont-Ferrand, Auvergne, France

Outcomes

Primary Outcomes

Frequency and grade of mucositis

Time frame: each visit

Secondary Outcomes

Effect on treatment conditions (interruption, doses)

Time frame: each visit

Other complications linked to chemoradiotherapy

Time frame: each week of chemoradiotherapy

Nutritional and immune status

Time frame: at randomisation's visit, visit at the end of treatment, 1, 6 and 12 months after the end of treatment

Life quality

Time frame: at randomisation's visit, visit at the end of treatment, 6 and 12 months after the end of treatment

Cost

Time frame: each visit

Data from ClinicalTrials.gov

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