Other Dietary Supplements

All Drugs and Chemicals

Amino Acids

Omega 3 Fatty Acid

Arginine

Whey Protein

Powdered formula containing whey protein and arginine (Active A) and lipid bolus containing omega 3 fatty acids. Participants will mix the powder (Active A) with 250 mL of water and drink the formula 3 times per day for 5 days. Each drink will be followed by consuming 1 tsp of the lipid bolus. This will be done for 5 days prior to the operation and for 5 days after the operation.

Powdered formula containing whey protein and arginine (Active A) and placebo oil. Participants will mix the powder (Active A) with 250 mL of water and drink the formula 3 times per day for 5 days. Each drink will be followed by consuming 1 tsp of the lipid bolus. This will be done for 5 days prior to the operation and for 5 days after the operation.

Powdered formula containing whey protein (Active B) and placebo oil. Participants will mix the powder (Active B) with 250 mL of water and drink the formula 3 times per day for 5 days. Each drink will be followed by consuming 1 tsp of the lipid bolus. This will be done for 5 days prior to the operation and for 5 days after the operation.

Powdered formula containing whey protein and arginine

Active A

Active B

Lipid bolus

Control placebo oil that does not contain omega-3 fatty acids

Placebo oil

Paul Karanicolas, MD, PhD

This is a randomized controlled blinded superiority trial to evaluate the impact of perioperative immunosupplementation on immune function following resection for hepatopancreaticobiliary (HPB) malignancy.

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.

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

Reduction in NK cell killing as measured on post-operative day one (POD1) as compared to baseline (pre-operative) between the control and experimental cohorts. Nutritional supplementation will be considered effective at reducing postoperative NK cell dysfunction if there is a 50% or greater improvement in postoperative suppression of NK cell cytotoxicity (reduction of 27% from baseline).

Flow cytometric analysis of different immune cell subsets to compare their proportions at all time points.

Flow cytometric characterization of NK cell activating and inhibitory receptors to assess whether they are affected by immunosupplementation.

Systemic blood levels of amino acids will be measured via liquid chromatography-mass spectrometry protein card analysis.

Pancreatic fistula of International Study Group on Pancreatic Fistula (ISGPF) Grade B \& C (i.e. clinically significant) will be diagnosed clinically.

Wound complications including dehiscence and infection will be diagnosed clinically.

Length of stay will be measured as number of days from admission to discharge.

Postoperative complications with Clavien-Dindo Grades 3-5 (i.e. requiring procedural intervention or ICU admission, or causing death) will be recorded.

The incidence of readmission within 90 days of surgery will be recorded as the number of days associated with each re-admission.

Death within 90 days of surgery will be considered complications of the surgery.

Posthepatectomy liver failure of International Study Group of Liver Surgery (ISGLS) Grade B \& C (i.e. clinically significant) will be diagnosed clinically

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The HepatoPancreaticoBiliary Resection Arginine Immunomodulation (PRIMe) Trial	NCT04549662	Hepatopancreati... Surgery	Active A Active B Lipid bolus Placebo oil	18 Years -	Sunnybrook Health Sciences Centre
The HepatoPancreaticoBiliary Resection Arginine Immunomodulation (PRIMe) Trial	NCT04549662	Hepatopancreati... Surgery	Active A Active B Lipid bolus Placebo oil	18 Years -	Sunnybrook Health Sciences Centre

Spots Global Cancer Trial Database for placebo oil

Every month we try and update this database with for placebo oil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for placebo oil

Every month we try and update this database with for placebo oil cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for placebo oil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.