The HepatoPancreaticoBiliary Resection Arginine Immunomodulation (PRIMe) Trial (PRIMe)

  • STATUS
    Recruiting
  • End date
    Dec 30, 2025
  • participants needed
    45
  • sponsor
    Sunnybrook Health Sciences Centre
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Updated on 14 June 2022
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adenocarcinoma

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.

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.

Details
Condition Hepatopancreaticobiliary (HPB) Malignancy, Surgery
Treatment Placebo oil, Active A, Active B, Lipid bolus
Clinical Study IdentifierNCT04549662
SponsorSunnybrook Health Sciences Centre
Last Modified on14 June 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients age 18 and over at time of diagnosis
Resectable presumed liver, pancreas, or bile duct malignancy (i.e., liver metastases, HCC, cholangiocarcinoma, pancreatic or periampullary adenocarcinoma, NETs)as determined by surgeon in clinic
Anticipated hospital stay at least three days post-surgery
Ability to tolerate oral intake and comply with protocol requirements

Exclusion Criteria

Documented significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids, azathioprine, cyclosporin A). Subjects may be on physiologic doses of replacement prednisone or equivalent doses of corticosteroid (<7.5 mg daily)
Subjects with resting hypotension (BP <90/50 at rest)
History of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis
Serious, active, intercurrent chronic or acute illness, or other active illness considered by the investigator as an unwarranted high risk for an investigational product
Active infection of any site and/or active herpes requiring ongoing treatment
Known pregnancy or nursing mothers
Subjects with an allergy to the nutritional supplement or comparator including milk, fish and/or shellfish allergies
Subjects with religious or other objections to consuming fish or shellfish
Subjects with severe asthma defined as asthma not controlled with inhaled corticosteroids and additional controllers or by oral corticosteroid treatment (arginine can cause allergic response or make swelling in airways worse)
Subjects with a known inherited guanidinoacetate methyltransferase deficiency (due to an inability to convert arginine to creatine)
Subject with known current liver cirrhosis
Subjects with documented myocardial infarction or life-threatening arrhythmia
Subjects with known current cardiac failure or coronary artery disease causing unstable angina
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