Clinical Trial

Monitoring and Managing Glucose Levels in People With Pancreatic Cancer

Study acronym: PEGASUS
Recruiting
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Summary
This study will investigate whether or not it is feasible to closely monitor and manage glucose levels in people with pancreatic cancer. It will also investigate what impact glucose management may have on pancreatic cancer. This is a pilot study that will use continuous glucose monitors (CGM) to monitor glucose levels in approximately 50 participants with pancreatic cancer. Participants will receive standard chemotherapy with a combination of up to four drugs to treat their pancreatic cancer: oxaliplatin, irinotecan, 5-fluorouracil, and leucovorin (FOLFIRINOX). To treat high glucose levels, participants will be randomly assigned to one of two groups: Group 1 will receive anti-hyperglycemic treatment as guided by an endocrinologist with the aim of maintaining glucose levels between 4 and 10 mmol/L; Group 2 will receive anti-hyperglycemic treatment if their glucose levels are above 15 mmol/L, which is standard care. Participants in both Groups 1 and 2 will receive standard anti-hyperglycemic treatments: metformin, insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, sodium glucose co-transporter (SGLT2) inhibitors, and dipeptidyl peptidase 4 (DPP-4) inhibitors. After 4 cycles of FOLFIRINOX, the CGM will be removed but any anti-hyperglycemic treatments will continue as needed. If participants discontinue treatment with FOLFIRINOX, they will continue to be followed for survival and subsequent anti-cancer therapy and will continue follow-up for glucose-related concerns at the discretion of their endocrinologist and/or medical oncologist.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-11-22; most recent amendment 2025-09-17.
Status change: Not Yet Recruiting → Recruiting 2024-02-08
Trial Details
NCT Number NCT05132244
Lead Sponsor British Columbia Cancer Agency
Collaborators: University of British Columbia, Lustgarten Foundation, University Health Network, Toronto
Conditions Pancreatic Cancer, PDAC - Pancreatic Ductal Adenocarcinoma, Hyperglycemia
Enrollment 50 participants
Start Date 2024-04-16
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2025-09-22