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Spots Global Cancer Trial Database for INEC Study: Immuno-modulating Enteral Nutrition in Cancer

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Trial Identification

Brief Title: INEC Study: Immuno-modulating Enteral Nutrition in Cancer

Official Title: Effect of Enteral Immunonutrition During Chemoradiotherapy in Patients With Head and Neck Cancer or Esophageal Cancer

Study ID: NCT00333099

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hotel Dieu, Clermont-Ferrand, Auvergne, France

Contact Details

Name: Corinne Bouteloup, Doctor

Affiliation: Hotel Dieu Service d'Hepato-Gastro-Enterologie (service du Pr G. Bommelaer) Clermont-Ferrand

Role: PRINCIPAL_INVESTIGATOR

Name: Marie-Paule Vasson, Professor

Affiliation: CLAN, Unité de Nutrition, Centre Jean Perrin (Clermont-Ferrand)

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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