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The HepatoPancreaticoBiliary Resection Arginine Immunomodulation (PRIMe) Trial

NCT04549662 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-04-03

No results posted yet for this study

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.

Conditions

  • Hepatopancreaticobiliary (HPB) Malignancy
  • Surgery

Interventions

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

Sponsors & Collaborators

  • Enhanced Medical Nutrition

    collaborator INDUSTRY

  • Sunnybrook Health Sciences Centre Clinical Research Grant Competition

    collaborator UNKNOWN

  • Sunnybrook Health Sciences Centre AFP Innovation Fund

    collaborator UNKNOWN

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Paul Karanicolas, MD, PhD · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-16
Primary Completion
2024-02-12
Completion
2024-02-12

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04549662 on ClinicalTrials.gov