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

Sponsors and Collaborators:	University of Dublin, Trinity College Abbott
Information provided by:	University of Dublin, Trinity College
ClinicalTrials.gov Identifier:	NCT00790140

Purpose

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.

Condition	Intervention	Phase
Esophageal Cancer	Dietary Supplement: Prosure Dietary Supplement: Ensure Plus	Phase IV

MedlinePlus related topics: Cancer Dietary Supplements Esophageal Cancer Esophagus Disorders

Drug Information available for: Eicosapentaenoic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	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

Further study details as provided by University of Dublin, Trinity College:

Primary Outcome Measures:

Preservation of body compostition after surgery [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduced immuno-inflammatory response to surgery [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	July 2005
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Immunonutrition Prosure: Active Comparator 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
Standard enteral nutrition Ensure Plus: Placebo Comparator 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

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790140

Contacts

Contact: Aoife Ryan, PhD	+35314284452	ryana1@tcd.ie
Contact: John V Reynolds, MD	+35314162211	reynoldsjv@stjames.ie

Locations

Ireland
St. James's Hospital,	Recruiting
Dublin, Ireland, 8
Contact: Aoife Ryan, PhD +35314284452 ryana1@tcd.ie
Contact: Laura A Healy +35314284452 lhealy@stjames.ie
Principal Investigator: John V Reynolds, MD

Sponsors and Collaborators

University of Dublin, Trinity College

Abbott

Investigators

Principal Investigator:

Laura A Healy, BSc RD

St. James's Hospital, Dublin 8, Ireland

More Information

Responsible Party:	St. James's Hospital, Dublin 8, Ireland ( Professor John V Reynolds, Professor of Surgery )
Study ID Numbers:	900/429/1
Study First Received:	November 12, 2008
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00790140
Health Authority:	Ireland: Irish Medicines Board

Keywords provided by University of Dublin, Trinity College:

Esophageal Cancer
esophagectomy
enteral feeding
body composition
immunology

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Head and Neck Neoplasms
Esophageal Neoplasms

Quality of Life
Gastrointestinal Neoplasms
Stress
Esophageal Diseases
Esophageal neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009