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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by University of Dublin, Trinity College.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
University of Dublin, Trinity College
ClinicalTrials.gov Identifier:
NCT00790140
First received: November 12, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  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 4

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

Resource links provided by NLM:


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
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 Name: 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 Name: Ensure Plus (Abbott Laboratories)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by University of Dublin, Trinity College

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor John V Reynolds, Professor of Surgery, St. James's Hospital, Dublin 8, Ireland
ClinicalTrials.gov Identifier: NCT00790140     History of Changes
Other Study ID Numbers: 900/429/1
Study First Received: November 12, 2008
Last Updated: November 12, 2008
Health Authority: Ireland: Irish Medicines Board

Keywords provided by University of Dublin, Trinity College:
Esophageal Cancer
esophagectomy
enteral feeding
body composition
immunology

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 31, 2014