Trial of Enteral Nutrition Enriched With Eicosapentaenoic Acid (EPA) in Upper Gastrointestinal Cancer Surgery
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
Esophageal Cancer, esophagectomy, enteral feeding, body composition, immunology
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Prosure Type: Dietary Supplement
Name: Ensure Plus Type: Dietary Supplement
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
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).
Location
St. James's Hospital,
Dublin, Ireland
Status: Recruiting
Contact: Aoife Ryan, PhD - +35314284452 - ryana1@tcd.ie
Start Date
July 2005
Completion Date
July 2010
Sponsors
University of Dublin, Trinity College
Source
University of Dublin, Trinity College
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page