Status:
COMPLETED
INEC Study: Immuno-modulating Enteral Nutrition in Cancer
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Fonds National d'Aménagement et de Développement du territoire (FNADT)
European Regional Development Fund
Conditions:
Malnutrition
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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), Novart...
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, ra...
Eligibility Criteria
Inclusion
- H\&N and esophageal cancer patients, not treated by surgery and needing chemoradiotherapy
- Performance status: Objective Mucositis Score (OMS) of 0, 1, 2 or Karnofsky \> 50%
- Acceptance of a gastrostomy, jejunostomy or a nasogastric tube to conduct enteral nutrition
- Informed consent form signed
Exclusion
- H\&N cancer treated by exclusive radiotherapy
- H\&N and esophageal cancer which can be treated by exclusive surgery
- Tonsil cancer
- Existence of metastases
- Concomitant cancer
- Repeat of cancer at site
- Insulin dependant diabetes
- Thyroid diseases
- Subjects with major surgery or severe infectious status in the 3 preceding months
- Biological assessment incompatible with the esophagus chemotherapy treatment (polynuclear cells \< 1500/ml; blood platelets \< 100000/ml; serum creatinine \> 130 µmol/ml; ASAT, ALAT, ALP and bilirubin \> twice the norm)
- Patients taking food or supplements enriched with omega 3 (arginine and nucleotides), during the period of the study and in the preceding month
- Breast feeding women or in period of fertility without effective means of contraception
- Patients who refuse to participate or are unable to receive information or are unable to sign written informed consent.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00333099
Start Date
May 1 2006
End Date
September 1 2011
Last Update
September 14 2012
Active Locations (1)
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1
Hotel Dieu
Clermont-Ferrand, Auvergne, France, 63058