Immunomodulation Therapy for Hepatopancreaticobiliary Cancer
(PRIMe Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByPaul Karanicolas, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sunnybrook Health Sciences Centre

Trial Summary

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

Eligibility Criteria

Adults diagnosed with resectable liver, pancreas, or bile duct malignancies who can stay in the hospital for at least three days post-surgery and tolerate oral intake. Excluded are those with significant immunodeficiency, serious illnesses posing high risk, active infections, pregnant/nursing women, fish/shellfish objections or allergies including milk allergy, certain heart conditions or severe asthma.

Inclusion Criteria

I was 18 or older when I was diagnosed.

My liver, pancreas, or bile duct cancer is considered operable by my surgeon.

Ability to tolerate oral intake and comply with protocol requirements

+1 more

Exclusion Criteria

I have been diagnosed with liver cirrhosis.

I do not have any ongoing infections or herpes requiring treatment.

You are allergic to the nutritional supplement or comparator, which includes milk, fish, and/or shellfish.

+10 more

Participant Groups

The trial is testing if perioperative immunosupplementation (Active A or Active B) versus a placebo oil affects immune function after surgery for HPB cancer. It's a blinded study where patients don't know if they're getting the real treatment or placebo.

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Group AExperimental Treatment2 Interventions

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.

Group II: Group BActive Control2 Interventions

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.

Group III: ComparatorPlacebo Group2 Interventions

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.