Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ensure Plus | Dietary Supplement | — | UNRESOLVED |
| Prosure | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Immunonutrition Prosure
- description
- 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
- interventionNames
- Dietary Supplement: Prosure
- type
- PLACEBO_COMPARATOR
- label
- Standard enteral nutrition Ensure Plus
- description
- This group are to be given a standard enteral tube feed without EPA for 5 days pre op and 21 days post surgery
- interventionNames
- Dietary Supplement: Ensure Plus
Primary outcomes (1)
- measure
- Preservation of body compostition after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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).
References
Publications (2)
- DERIVEDHealy 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 28742713
- DERIVEDRyan 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 19247018