INEC Study: Immuno-modulating Enteral Nutrition in Cancer

Phase 4

Completed

• Conditions: Malnutrition; Esophageal Cancer; Head and Neck Cancer
• Interventions: Dietary Supplement: Impact (R) Enteral Nutrition; Other: impact

• Registration Number: NCT00333099
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-06-01
• Study First Submitted QC: 2006-06-01
• Study First Posted: 2006-06-02
• Primary Completion: 2010-09
• Study Completion: 2011-09
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-13
• Last Update Posted: 2012-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nutrition	Impact (R) Enteral Nutrition	study of immuno-modulating enteral nutrition
nutrition	impact	study of immuno-modulating enteral nutrition

Primary Outcome Measures

Name	Time	Method
Frequency and grade of mucositis	each visit

Secondary Outcome Measures

Name	Time	Method
Other complications linked to chemoradiotherapy	each week of chemoradiotherapy
Effect on treatment conditions (interruption, doses)	each visit
Nutritional and immune status	at randomisation's visit, visit at the end of treatment, 1, 6 and 12 months after the end of treatment
Life quality	at randomisation's visit, visit at the end of treatment, 6 and 12 months after the end of treatment
Cost	each visit

Trial Locations

Locations (1)

Hotel Dieu; 🇫🇷 Clermont-Ferrand, Auvergne, France