Trials / Completed
CompletedNCT04549662
The HepatoPancreaticoBiliary Resection Arginine Immunomodulation (PRIMe) Trial
The HepatoPancreaticoBiliary Resection Arginine Immunomodulation (PRIMe) Trial: A Randomized Phase II Trial of the Impact of Perioperative Immunomodulation on Immune Function Following Resection for HepatoPancreaticoBiliary Malignancy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Sunnybrook Health Sciences Centre · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized controlled blinded superiority trial to evaluate the impact of perioperative immunosupplementation on immune function following resection for hepatopancreaticobiliary (HPB) malignancy.
Detailed description
This is a 1:1:1 randomized controlled blinded superiority trial to evaluate the impact of perioperative immunosupplementation on immune function following resection for hepatopancreaticobiliary (HPB) malignancy. Two variations of immunosupplementation will be compared to control nutritional supplement containing whey protein with an additional teaspoon (tsp) of placebo oil. These variations will be 1) a powdered formula containing whey protein and arginine (Active A) with an additional tsp of lipid bolus containing omega-3 fatty acids, and 2) a powdered formula containing whey protein and arginine (Active A) with an additional tsp of placebo oil which does not contain omega-3 fatty acids. The control nutritional supplement will be a powdered formula containing whey protein with an additional tsp of placebo oil.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Active A | Powdered formula containing whey protein and arginine |
| DIETARY_SUPPLEMENT | Active B | Powdered formula containing whey protein |
| DIETARY_SUPPLEMENT | Lipid bolus | Omega-3 fatty acids |
| DIETARY_SUPPLEMENT | Placebo oil | Control placebo oil that does not contain omega-3 fatty acids |
Timeline
- Start date
- 2021-06-16
- Primary completion
- 2024-02-12
- Completion
- 2024-02-12
- First posted
- 2020-09-16
- Last updated
- 2024-04-03
Locations
2 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT04549662. Inclusion in this directory is not an endorsement.