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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Dietary Supplement: Prosure
* Dietary Supplement: Ensure Plus


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immunonutrition Prosure<br>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<br>* 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<br>* Other names: Prosure (Abbott Laboratories);|
| Placebo Comparator: Standard enteral nutrition Ensure Plus<br>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<br>* 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<br>* Other names: Ensure Plus (Abbott Laboratories);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preservation of body compostition after surgery |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced immuno-inflammatory response to surgery |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Cancer, esophagectomy, enteral feeding, body composition, immunology