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

2014-08-27 03:26:19 | BioPortfolio

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.

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 Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Esophageal Cancer

Intervention

Prosure, Ensure Plus

Location

St. James's Hospital,
Dublin
Ireland
8

Status

Recruiting

Source

University of Dublin, Trinity College

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:26:19-0400

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Medical and Biotech [MESH] Definitions

Tumors or cancer of the ESOPHAGUS.

A pathological condition characterized by the presence of a number of ESOPHAGEAL DIVERTICULA in the ESOPHAGUS.

Surgical incision of the lower esophageal sphincter near the CARDIA often used to treat ESOPHAGEAL ACHALASIA.

Circular innermost layer of the ESOPHAGUS wall that mediates esophageal PERISTALSIS which pushes ingested food bolus toward the stomach.

Disorders affecting the motor function of the UPPER ESOPHAGEAL SPHINCTER; LOWER ESOPHAGEAL SPHINCTER; the ESOPHAGUS body, or a combination of these parts. The failure of the sphincters to maintain a tonic pressure may result in gastric reflux of food and acid into the esophagus (GASTROESOPHAGEAL REFLUX). Other disorders include hypermotility (spastic disorders) and markedly increased amplitude in contraction (nutcracker esophagus).

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