Effect of Enteral Immunonutrition During Chemoradiotherapy in Patients With Head and Neck Cancer or Esophageal Cancer
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Frequency and grade of mucositis
each visit
No
Corinne Bouteloup, Doctor
Principal Investigator
Hotel Dieu Service d'Hepato-Gastro-Enterologie (service du Pr G. Bommelaer) Clermont-Ferrand
France: Ministry of Health
CHU63-0012
NCT00333099
May 2006
September 2011
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