The Pancreatic and Periampullary Resection, Arginine Immunomodulation (PPRIMe) Trial: A Multi-Centre Randomized-Controlled Phase II Trial of the Impact of Perioperative Immunomodulation on Immune Function following Resection for Pancreatic or Periampullary Adenocarcinoma

Project Code

Project Title

The Pancreatic and Periampullary Resection, Arginine Immunomodulation (PPRIMe) Trial: A Multi-Centre Randomized-Controlled Phase II Trial of the Impact of Perioperative Immunomodulation on Immune Function following Resection for Pancreatic or Periampullary Adenocarcinoma

Proposal Abstract

Background: Patients undergoing resection for pancreatic or periampullary adenocarcinoma experience frequent recurrence and poor overall survival. Long-term oncologic and short-term perioperative benefits associated with supraphysiologic arginine have been demonstrated in other patient populations. The impact of immunosupplementation on immune function has not been studied in patients with pancreatic or periampullary adenocarcinoma. Methods: This is a multi-centre phase II randomized placebo-controlled trial of immunomodulation with supraphysiologic arginine in patients undergoing resection for pancreatic or periampullary adenocarcinoma. The primary outcome is post-operative immune function. Discussion: Poor survival outcomes and high rates of anastomotic leak and infectious complications have long been associated with surgery for pancreatic cancer. Previous studies have shown an improvement in immune function in other patient populations undergoing surgery for malignancy with perioperative immunomodulation. This improvement in immune function may be associated with increased survival as well as a reduction in infectious complications and anastomotic leaks.

Reporting Abstract

The purpose of this clinical trial is to determine if a natural health product containing either supraphysiologic levels of arginine and/or supraphysiologic levels of arginine and omega-3 fatty acids can improve immune function in patients undergoing pancreas surgery. A total of 45 interested and eligible participants will be randomized to one of three groups at Sunnybrook Hospital and The Ottawa Hospital: 1) control nutritional supplement containing whey protein; 2) nutritional supplement containing whey protein and arginine; or 3) nutritional supplement containing whey protein, arginine and omega-3 fatty acids. Participants will be asked to consume the supplement for five days pre-operatively and five days post-operatively. Immune function will be measured in study specific blood samples collected at five time points: 1) baseline; 2) pre-operatively after consumption; 3) post-operative day one; 4) post-operative day five; and 5) post-operative day 30. Participants will be asked to complete questionnaires at post-operative day 30 and 90 and will be followed for three years after surgery. Due to significant delays, we have been unable to begin recruitment. The PRIMe trial will be continuing until recruitment has been completed.

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Primary Project Lead for Contact

SHS - Sunnybrook Medical Services Alternative Funding Plan Association

Project Summary

The Pancreatic and Periampullary Resection, Arginine Immunomodulation (PPRIMe) Trial: A Multi-Centre Randomized-Controlled Phase II Trial of the Impact of Perioperative Immunomodulation on Immune Function following Resection for Pancreatic or Periampullary Adenocarcinoma

SHS - Sunnybrook Medical Services Alternative Funding Plan Association

Project Summary

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