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

November 12, 2008 updated by: University of Dublin, Trinity College

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, 8
        • Recruiting
        • St. James's Hospital,
        • Contact:
          • Aoife Ryan, PhD
          • Phone Number: +35314284452
          • Email: ryana1@tcd.ie
        • Contact:
        • Principal Investigator:
          • John V Reynolds, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immunonutrition 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
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
Other Names:
  • Prosure (Abbott Laboratories)
Placebo Comparator: Standard enteral nutrition 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
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
Other Names:
  • Ensure Plus (Abbott Laboratories)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Preservation of body compostition after surgery
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduced immuno-inflammatory response to surgery
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dublin, Trinity College

Collaborators

Abbott

Investigators

  • Principal Investigator: Laura A Healy, BSc RD, St. James's Hospital, Dublin 8, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Anticipated)

July 1, 2010

Study Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

November 12, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Estimate)

November 13, 2008

Last Update Submitted That Met QC Criteria

November 12, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 900/429/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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