CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 250 enrolled
Drug / intervention
Impact (R) Enteral Nutrition +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00333099
NCT00333099Phase 4Completed
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Effect of Enteral Immunonutrition During Chemoradiotherapy in Patients With Head and Neck Cancer or Esophageal Cancer

University Hospital, Clermont-Ferrand·interventional·Posted Jun 2, 2006·Updated Sep 14, 2012

In Brief

A Phase 4 clinical trial evaluating Impact (R) Enteral Nutrition and impact for Malnutrition and 2 related conditions. Completed, enrolled 250 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalnutrition, Esophageal Cancer, Head and Neck Cancer
CountriesFrance
CollaboratorsFonds National d'Aménagement et de Développement du territoire (FNADT), European Regional Development Fund, Centre Jean Perrin, Centre Leon Berard, Institut de Cancérologie de la Loire, Centre Hospitalier Universitaire de Saint Etienne, Hôpital Edouard Herriot, University Hospital, Grenoble, Orkyn', Novartis

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2, 2006
Enrollment StartMay 1, 2006
Primary CompletionSep 1, 2010
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.1 years ago

Interventions

Impact (R) Enteral Nutritiondietary

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