Trial of Enteral Nutrition Enriched With Eicosapentaenoic Acid (EPA) in Upper Gastrointestinal Cancer Surgery
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
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2005
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 12, 2008
CompletedFirst Posted
Study publicly available on registry
November 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedNovember 13, 2008
November 1, 2008
5 years
November 12, 2008
November 12, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Preservation of body compostition after surgery
2 months
Secondary Outcomes (1)
Reduced immuno-inflammatory response to surgery
2 months
Study Arms (2)
Immunonutrition Prosure
ACTIVE COMPARATORThis 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
Standard enteral nutrition Ensure Plus
PLACEBO COMPARATORThis group are to be given a standard enteral tube feed without EPA for 5 days pre op and 21 days post surgery
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Adult (male \& female) patients \>18 years with resectable esophageal cancer
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Dublin, Trinity Collegelead
- Abbottcollaborator
Study Sites (1)
St. James's Hospital,
Dublin, 8, Ireland
Related Publications (2)
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.
PMID: 28742713DERIVEDRyan 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.
PMID: 19247018DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura A Healy, BSc RD
St. James's Hospital, Dublin 8, Ireland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 12, 2008
First Posted
November 13, 2008
Study Start
July 1, 2005
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
November 13, 2008
Record last verified: 2008-11