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

Sponsor

University of Dublin, Trinity College (Other)

Overall Status

Unknown status

CT.gov ID

NCT00790140

Collaborator

Abbott (Industry)

120

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2005

Anticipated Primary Completion Date :

Jul 1, 2010

Anticipated Study Completion Date :

Jul 1, 2010

Arms and Interventions

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 Names: 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 Names: Ensure Plus (Abbott Laboratories)

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 Names:

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 Names:

Ensure Plus (Abbott Laboratories)

Outcome Measures

Primary Outcome Measures

Preservation of body compostition after surgery [2 months]

Secondary Outcome Measures

Reduced immuno-inflammatory response to surgery [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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).