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

Esophageal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00790140
• Other study ID #: 900/429/1
• Status: Recruiting
• Phase: Phase 4
• First received: November 12, 2008
• Last updated: November 12, 2008
• Start date: July 2005
• Est. completion date: July 2010

Study information

• Verified date: November 2008
• Source: University of Dublin, Trinity College
• Contact: Aoife Ryan, PhD
• Phone: +35314284452
• Email: ryana1[@]tcd.ie
• Is FDA regulated: No
• Health authority: Ireland: Irish Medicines Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Ireland	St. James's Hospital,	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
University of Dublin, Trinity College	Abbott

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preservation of body compostition after surgery		2 months	No
Secondary	Reduced immuno-inflammatory response to surgery		2 months	No