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Omega 3 Fatty Acid

This group of patients are to be given a tube feed enriched with 2.2 g Eicosapentaenoic Acid (EPA) per day for 5 days pre surgery and 21 days post surgery

This group are to be given a standard enteral tube feed without EPA for 5 days pre op and 21 days post surgery

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

Prosure

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

Ensure Plus

Aoife Ryan, PhD

John V Reynolds, MD

Laura A Healy

Laura A Healy, BSc RD

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.

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

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

Abbott

University of Dublin, Trinity College

Professor John V Reynolds, Professor of Surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of Enteral Nutrition Enriched With Eicosapentaenoic Acid (EPA) in Upper Gastrointestinal Cancer Surgery	NCT00790140	Esophageal Canc...	Prosure Ensure Plus	18 Years - 80 Years	University of Dublin, Trinity College
Trial of Enteral Nutrition Enriched With Eicosapentaenoic Acid (EPA) in Upper Gastrointestinal Cancer Surgery	NCT00790140	Esophageal Canc...	Prosure Ensure Plus	18 Years - 80 Years	University of Dublin, Trinity College

Spots Global Cancer Trial Database for ensure plus

Every month we try and update this database with for ensure plus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ensure plus

Every month we try and update this database with for ensure plus cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ensure plus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.