Clinical trial NCT00790140: Trial of Enteral Nutrition Enriched With Eicosapentaenoic Acid (EPA) in Upper Gastrointestinal Cancer Surgery
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Esophageal Cancer
Keywords: Esophageal Cancer
esophagectomy
enteral feeding
body composition
immunology
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2008-11-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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).

Primary outcomes:
measure: Preservation of body compostition after surgery
timeFrame: 2 months
Secondary outcomes:
measure: Reduced immuno-inflammatory response to surgery
timeFrame: 2 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St. James's Hospital,
Study officials:
affiliation: St. James's Hospital, Dublin 8, Ireland
name: Laura A Healy, BSc RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.