About this trial
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.
Eligibility criteria
Qualifiers
Histological/cytological diagnosis of pancreatic ductal adenocarcinoma (PDAC).
Planned to undergo first-line systemic therapy with FOLFIRINOX.
Age greater than or equal to 18 years.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Disqualifiers
Absence of distant or lymph node metastases. Participants with borderline resectable or locally advanced PDAC are not eligible.
Received prior systemic therapy (chemotherapy or any other anti-cancer agent) for treatment of metastatic PDAC. Participants who received adjuvant chemotherapy after surgical resection of early stage disease are eligible.
Currently receiving anti-cancer therapy (chemotherapy or any other anti-cancer agent).
Not fit for combination chemotherapy as judged by the study doctor.
Trial design
Treatments tested in this trial
- Endocrinologist-directed target blood glucose level 4-10 mmol/L using data from a continuous glucose monitor (CGM)
- Standard Care
Treatment groups
Sponsors and collaborators
British Columbia Cancer Agency
Lead sponsor
University of British Columbia
Collaborator
Lustgarten Foundation
Collaborator
University Health Network, Toronto
Collaborator