Actively Recruiting
Monitoring and Managing Glucose Levels in People With Pancreatic Cancer
Led by British Columbia Cancer Agency · Updated on 2025-09-22
50
Participants Needed
2
Research Sites
154 weeks
Total Duration
On this page
Sponsors
B
British Columbia Cancer Agency
Lead Sponsor
U
University of British Columbia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Monitoring and Managing Glucose Levels in People With Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological diagnosis of pancreatic ductal adenocarcinoma (PDAC).
- Planned to undergo first-line systemic therapy with FOLFIRINOX.
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate bone marrow and organ function including:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L.
- Platelet count ≥ 75 x 10^9/L.
- Hemoglobin ≥ 9.0 g/dL.
- Estimated glomerular filtration rate (GFR) or 24-hour urine collection ≥ 40 ml/min.
- Creatinine clearance ≥ 40 mL/min by Cockcroft-Gault formula.
- Potassium normal or corrected with supplements.
- International normalized ratio (INR) ≤ 1.5.
- Total serum bilirubin ≤ 2 x upper limit of normal (ULN), except Gilbert's syndrome cases with ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (or ≤ 5 x ULN if liver metastases present).
- Able to understand and voluntarily sign informed consent.
- Able to comply with study visits and protocol requirements.
- Able to swallow oral medications and tolerate subcutaneous insulin injections.
- Measurable or evaluable disease by RECIST 1.1 at baseline.
- Life expectancy over 90 days as judged by the study doctor.
You will not qualify if you...
- No distant or lymph node metastases; borderline resectable or locally advanced PDAC not eligible.
- Prior systemic therapy for metastatic PDAC (adjuvant chemotherapy after surgery allowed).
- Currently receiving any anti-cancer therapy.
- Not fit for combination chemotherapy as judged by the study doctor.
- Presence of brain metastases.
- Known type I diabetes requiring strict glucose control and endocrinology follow-up.
- Known type II diabetes already followed by an endocrinologist.
- Female participants with a positive pregnancy test.
- Deemed unsafe for study participation by the study doctor for any medical or non-medical reason.
- Unable to comply with study assessments and follow-up.
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Trial Site Locations
Total: 2 locations
1
British Columbia Cancer
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
2
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
D
Daniel Renouf, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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