INEC Study: Immuno-modulating Enteral Nutrition in Cancer

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.

Conditions

• Malnutrition
• Esophageal Cancer
• Head and Neck Cancer

Interventions

DIETARY_SUPPLEMENT

Impact (R) Enteral Nutrition

mucositis frequency, treatment tolerance

OTHER

impact

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

Sponsors & Collaborators

• Fonds National d'Aménagement et de Développement du territoire (FNADT)

  collaborator UNKNOWN

• European Regional Development Fund

  collaborator OTHER

• Centre Jean Perrin

  collaborator OTHER

• Centre Leon Berard

  collaborator OTHER

• Institut de Cancérologie de la Loire

  collaborator OTHER

• Centre Hospitalier Universitaire de Saint Etienne

  collaborator OTHER

• Hôpital Edouard Herriot

  collaborator OTHER

• University Hospital, Grenoble

  collaborator OTHER

• Orkyn'

  collaborator INDUSTRY

• Novartis

  collaborator INDUSTRY

• University Hospital, Clermont-Ferrand

  lead OTHER

Principal Investigators

• Corinne Bouteloup, Doctor · Hotel Dieu Service d'Hepato-Gastro-Enterologie (service du Pr G. Bommelaer) Clermont-Ferrand

• Marie-Paule Vasson, Professor · CLAN, Unité de Nutrition, Centre Jean Perrin (Clermont-Ferrand)

Study Design

Allocation

RANDOMIZED

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-05-31

Primary Completion

2010-09-30

Completion

2011-09-30

Countries

• France

Study Locations