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

University of Dublin, Trinity College

Status and phase: Unknown; Phase 4

Conditions: Esophageal Cancer

Treatments: Dietary Supplement: Ensure Plus; Dietary Supplement: Prosure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00790140

900/429/1

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Immunonutrition Prosure

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Prosure

Standard enteral nutrition Ensure Plus

Placebo Comparator group

Description:

This group are to be given a standard enteral tube feed without EPA for 5 days pre op and 21 days post surgery

Treatment:

Dietary Supplement: Ensure Plus