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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prosure | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Preservation of body compostition after surgery | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reduced immuno-inflammatory response to surgery | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aoife Ryan, PhD | Contact | +35314284452 | ryana1@tcd.ie | |
| John V Reynolds, MD | Contact | +35314162211 | reynoldsjv@stjames.ie |
| Name | Affiliation | Role |
|---|---|---|
| Laura A Healy, BSc RD | St. James's Hospital, Dublin 8, Ireland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. James's Hospital, | Recruiting | Dublin | 8 | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28742713 | Derived | 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. | |
| 19247018 |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C029401 | Ensure Plus |
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| Ensure Plus | Dietary Supplement | 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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| 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. |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |