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

Phase 4

• Conditions: Esophageal Cancer
• Interventions: Dietary Supplement: Ensure Plus; Dietary Supplement: Prosure

• Registration Number: NCT00790140
• Lead Sponsor: University of Dublin, Trinity College

Brief 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

Study Timeline

• Study Start: 2005-07
• Status Verified: 2008-11
• Study First Submitted: 2008-11-12
• Study First Submitted QC: 2008-11-12
• Last Update Submitted: 2008-11-12
• Study First Posted: 2008-11-13
• Last Update Posted: 2008-11-13
• Primary Completion: 2010-07
• Study Completion: 2010-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Adult (male & female) patients >18 years with resectable esophageal cancer

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Exclusion Criteria

• Patients with metastatic disease,
• Non-operable cases,
• Patients requiring chemotherapy/radiotherapy early following surgery,
• Patients with known immunological disorder,
• Emergency esophagectomy cases,
• Patients with cardiac, liver or renal failure,
• Active small intestinal disease eg Crohns disease,
• Allergy to any of the ingredients,
• Uncontrollable Diabetes,
• Use of medications known to affect eicosanoid metabolism in two weeks prior to trial,
• Use of fish oil/n-3 fatty acids,
• Drug Abuse,
• Unable to take preparation for 5 days preoperatively,
• Pregnant women,
• Cessation of enteral feeding for longer than 3 consecutive days post operatively for medical/surgical reasons (e.g. Chyle leaks).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard enteral nutrition Ensure Plus	Ensure Plus	This group are to be given a standard enteral tube feed without EPA for 5 days pre op and 21 days post surgery
Immunonutrition Prosure	Prosure	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

Primary Outcome Measures

Name	Time	Method
Preservation of body compostition after surgery	2 months

Secondary Outcome Measures

Name	Time	Method
Reduced immuno-inflammatory response to surgery	2 months

Trial Locations

Locations (1)

St. James's Hospital,; 🇮🇪 Dublin, Ireland