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Sponsors and Collaborators: |
University of Dublin, Trinity College Abbott |
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Information provided by: | University of Dublin, Trinity College |
ClinicalTrials.gov Identifier: | NCT00790140 |
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 | Intervention | Phase |
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Esophageal Cancer |
Dietary Supplement: Prosure Dietary Supplement: Ensure Plus |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 120 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Immunonutrition Prosure: Active Comparator
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
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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
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Standard enteral nutrition Ensure Plus: Placebo Comparator
This group are to be given a standard enteral tube feed without EPA for 5 days pre op and 21 days post surgery
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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
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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:
Secondary Endpoints:
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aoife Ryan, PhD | +35314284452 | ryana1@tcd.ie |
Contact: John V Reynolds, MD | +35314162211 | reynoldsjv@stjames.ie |
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 |
Principal Investigator: | Laura A Healy, BSc RD | St. James's Hospital, Dublin 8, Ireland |
Responsible Party: | St. James's Hospital, Dublin 8, Ireland ( Professor John V Reynolds, Professor of Surgery ) |
Study ID Numbers: | 900/429/1 |
Study First Received: | November 12, 2008 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00790140 History of Changes |
Health Authority: | Ireland: Irish Medicines Board |
Esophageal Cancer esophagectomy enteral feeding body composition immunology |
Digestive System Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Stress Quality of Life Esophageal Cancer Digestive System Diseases |
Esophageal Disorder Head and Neck Neoplasms Vitamins Omega 3 Fatty Acid Gastrointestinal Neoplasms Esophageal Diseases |
Neoplasms Neoplasms by Site Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Head and Neck Neoplasms Esophageal Neoplasms Gastrointestinal Neoplasms Esophageal Diseases |