Trial of Enteral Nutrition Enriched With Eicosapentaenoic Acid (EPA) in Upper Gastrointestinal Cancer Surgery
NCT ID: NCT00790140
Last Updated: 2008-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2005-07-31
2010-07-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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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
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
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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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).
18 Years
80 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
University of Dublin, Trinity College
OTHER
Responsible Party
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St. James's Hospital, Dublin 8, Ireland
Principal Investigators
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Laura A Healy, BSc RD
Role: PRINCIPAL_INVESTIGATOR
St. James's Hospital, Dublin 8, Ireland
Locations
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St. James's Hospital,
Dublin, , Ireland
Countries
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Central Contacts
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Facility Contacts
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Aoife Ryan, PhD
Role: primary
Laura A Healy
Role: backup
References
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Healy LA, Ryan A, Doyle SL, Ni Bhuachalla EB, Cushen S, Segurado R, Murphy T, Ravi N, Donohoe CL, Reynolds JV. Does Prolonged Enteral Feeding With Supplemental Omega-3 Fatty Acids Impact on Recovery Post-esophagectomy: Results of a Randomized Double-Blind Trial. Ann Surg. 2017 Nov;266(5):720-728. doi: 10.1097/SLA.0000000000002390.
Ryan AM, Reynolds JV, Healy L, Byrne M, Moore J, Brannelly N, McHugh A, McCormack D, Flood P. Enteral nutrition enriched with eicosapentaenoic acid (EPA) preserves lean body mass following esophageal cancer surgery: results of a double-blinded randomized controlled trial. Ann Surg. 2009 Mar;249(3):355-63. doi: 10.1097/SLA.0b013e31819a4789.
Other Identifiers
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900/429/1
Identifier Type: -
Identifier Source: org_study_id