NCT00790140

Trial of Enteral Nutrition Enriched With Eicosapentaenoic Acid (EPA) in Upper Gastrointestinal Cancer Surgery

Randomized Double Blinded Trial to Investigate Effects of an Enteral Nutritional Supplement Enriched With Eicosapentaenoic Acid on Body Composition,Complications,Stress Response,Immune Function & Quality of Life in After Esophagectomy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Dublin, Trinity College · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study aims to examine whether providing tube feeding with a formula enriched with omega-3 fats is better than traditional standard tube feeding in terms of preserving nutritional status, improving immune function and reducing medical complications following major upper Gut cancer surgery.

Detailed description

Title A double blinded randomized controlled trial to investigate the effects of an enteral nutritional supplement enriched with Eicosapentaenoic acid on long term nutritional status post operatively specifically the maintenance of lean body mass, and its potential impact on quality of life as well as examining the stress response and immune function and in patients undergoing surgical treatment of esophageal cancer. Investigational medicinal Product(s): Prosure (Abbott Laboratories) Comparator: Ensure Plus (Abbott Laboratories) Study Objectives To examine whether prolonged supplementation with a nutritional supplement enriched with Eicosapentaenoic acid is superior to standard nutritional products in terms of promoting anabolism and improving quality of life in patients undergoing surgical treatment of esophageal cancer. Study Design - Prospective randomized controlled trial. Primary Endpoints: * Quality of life Scores using EORTC Questionnaires * Nutritional status on day 21 post oesophagectomy and/or total gastrectomy(specifically lean body mass) and at out patient follow up Secondary Endpoints: * Effects on the immuno-inflammatory response to surgery * Post operative Clinical outcome including SIRS, sepsis and organ failure

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Prosure	This is an enteral tube feed with 125 kcals \& 6.65g protein per 100mls. It contains Fat, Carbohydrate, and vitamins and minerals and is enriched with 2.2g Eicosapentaenoic Acid per 500mls of feed. Patients on this trial who are randomized to Prosure will receive the product orally for 5 days prior to surgery and for 21 days post surgery vis a feeding jejunostomy tube
DIETARY_SUPPLEMENT	Ensure Plus	This is a standard enteral tube feed with 150 kcals \& 6.3 g protein per 100mls as well as carbohydrate, fat and vitamins and minerals. It does not have any active immunonutrients. Patients randomized to this arm will receive the product for 5 days pre op and 21 days post surgery via a feeding jejunostomy tube

Timeline

• Start date: 2005-07-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2008-11-13
• Last updated: 2008-11-13

Locations

1 site across 1 country: Ireland