Clinical trial · Interventional
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
NCT04549662CI-TRIAL-00075685PRIMecompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized controlled blinded superiority trial to evaluate the impact of perioperative immunosupplementation on immune function following resection for hepatopancreaticobiliary (HPB) malignancy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatopancreaticobiliary (HPB) Malignancy | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active A | Dietary Supplement | — | UNRESOLVED |
| Active B | Dietary Supplement | — | UNRESOLVED |
| Lipid bolus | Dietary Supplement | — | UNRESOLVED |
| Placebo oil | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group A
- description
- 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.
- interventionNames
- Dietary Supplement: Active A
- Dietary Supplement: Lipid bolus
- type
- ACTIVE_COMPARATOR
- label
- Group B
- description
- 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.
- interventionNames
- Dietary Supplement: Active A
- Dietary Supplement: Placebo oil
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBehman R, Auer RC, Bubis L, Xu G, Coburn NG, Martel G, Hallet J, Balaa F, Law C, Bertens KA, Abou Khalil J, Karanicolas PJ. Hepatopancreaticobiliary Resection Arginine Immunomodulation (PRIMe) trial: protocol for a randomised phase II trial of the impact of perioperative immunomodulation on immune function following resection for hepatopancreaticobiliary malignancy. BMJ Open. 2024 Apr 5;14(4):e072159. doi: 10.1136/bmjopen-2023-072159. PMID 38580363