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

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ClinicalTrials.gov Identifier: NCT00790140
Recruitment Status : Unknown
Verified November 2008 by University of Dublin, Trinity College.
Recruitment status was:  Recruiting
First Posted : November 13, 2008
Last Update Posted : November 13, 2008
Sponsor:
Collaborator:
Abbott
Information provided by:
University of Dublin, Trinity College

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Dietary Supplement: Prosure Dietary Supplement: Ensure Plus Phase 4

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2005
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. Preservation of body compostition after surgery [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Reduced immuno-inflammatory response to surgery [ Time Frame: 2 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790140


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

Locations
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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
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Principal Investigator: Laura A Healy, BSc RD St. James's Hospital, Dublin 8, Ireland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Professor John V Reynolds, Professor of Surgery, St. James's Hospital, Dublin 8, Ireland
ClinicalTrials.gov Identifier: NCT00790140    
Other Study ID Numbers: 900/429/1
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: November 13, 2008
Last Verified: November 2008
Keywords provided by University of Dublin, Trinity College:
Esophageal Cancer
esophagectomy
enteral feeding
body composition
immunology
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases