Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333099
Status:
COMPLETED
Last Update Posted:
2012-09-14
First Post:
2006-06-01
Brief Title:
INEC Study Immuno-modulating Enteral Nutrition in Cancer
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Effect of Enteral Immunonutrition During Chemoradiotherapy in Patients With Head and Neck Cancer or Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 HN 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 ImpactR 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None