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
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)
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.
- 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
- Effects on the immuno-inflammatory response to surgery
- Post operative Clinical outcome including SIRS, sepsis and organ failure
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Preservation of body compostition after surgery
Laura A Healy, BSc RD
St. James's Hospital, Dublin 8, Ireland
Ireland: Irish Medicines Board