Recruiting

Observational Study

Sponsor:

British Columbia Cancer Agency

Code:

NCT05132244

Conditions

Pancreatic Cancer

PDAC - Pancreatic Ductal Adenocarcinoma

Hyperglycemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endocrinologist-directed target blood glucose level 4-10 mmol/L using data from a continuous glucose monitor (CGM)

Standard Care

Study Details

Brief 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.

Conditions

Pancreatic Cancer

PDAC - Pancreatic Ductal Adenocarcinoma

Hyperglycemia

Study ID

NCT05132244

Start date

Apr 16, 2024

Status verified date

Sep, 2025

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • Adequate bone marrow and organ function as defined by the following laboratory values:

1. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9/L.
2. Platelet count greater than or equal to 75 x 10\^9/L.
3. Hemoglobin greater than or equal to 9.0 g/dL.
4. Estimated glomerular filtration rate (GFR) by Cockroft-Gault equation OR 24 hour urine collection greater than or equal to 40 ml/min.
5. Creatinine clearance greater than or equal to 40 mL/min using Cockcroft-Gault formula.
6. Potassium within normal limits, or corrected with supplements.
7. International normalized ratio (INR) less than or equal to 1.5.
8. Total serum bilirubin less than or equal to 2 x upper limit of normal (ULN) (any elevated bilirubin should be asymptomatic at enrollment) except for participants with documented Gilbert's syndrome who may only be included if the total bilirubin less than or equal to 3 x ULN or direct bilirubin less than or equal to 1.5 x ULN).
9. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 2.5 x ULN (or less than or equal to 5 x ULN if liver metastases are present).
  • Able to understand and voluntarily sign the informed consent form.
  • Able to comply with the study visit schedule and other protocol requirements.
  • Able to swallow oral medications and has no contraindications to subcutaneous insulin injections.
  • Measurable or evaluable disease by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at baseline.
  • Life expectancy of more than 90 days as judged by the study doctor.

Exclusion Criteria:

  • 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.
  • Presence of brain metastases.
  • Known diagnosis of type I diabetes where strict glucose control and close Endocrinology follow-up is already indicated.
  • Known diagnosis of type II diabetes and already followed by Endocrinologist.
  • Female participants with a positive pregnancy test.
  • Participants who are not safe to include in the study as judged by the study doctor for any medical or non-medical reason.
  • Unable to comply with study assessments and follow-up.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intensive Glucose Intervention

Participants will receive standard anti-hyperglycemic treatment as guided by an endocrinologist using a combination of data from a continuous glucose monitor (CGM) and standard blood work drawn prior to each cycle of chemotherapy. Treatment will aim to maintain glucose levels between 4 and 10 mmol/L. Participants will have real-time access to their glucose data via the CGM.

other: Standard Care

Participants will receive standard anti-hyperglycemic treatment only if blood glucose level is above 15 mmol/L as measured from standard blood work drawn prior to each cycle of chemotherapy. Participants will wear a CGM but will not be able to view their glucose data. Participants may be referred to an endocrinologist at the discretion of their medical oncologist.

Interventions

Endocrinologist-directed target blood glucose level 4-10 mmol/L using data from a continuous glucose monitor (CGM)

Standard anti-hyperglycemic treatment given as directed by an endocrinologist to maintain blood glucose level within 4-10 mmol/L based on data from a continuous glucose monitor (CGM) and standard blood work drawn prior to each cycle of chemotherapy. Participants will have access to their glucose data from the CGM.

Standard Care

Standard anti-hyperglycemic treatment given only if blood glucose level is greater than 15 mmol/L as measured from standard blood work drawn prior to each cycle of chemotherapy. Participants will wear a continuous glucose monitor (CGM) but will not have access to their glucose data. Participants may be referred to an endocrinologist at the discretion of their medical oncologist.

Primary outcome measure

  • Frequency of glucose levels maintained within range in Arm 1 compared to Arm 2 [ Time Frame: From the Cycle 4 FOLFIRINOX treatment date to the Cycle 5 FOLFIRINOX treatment date (each cycle is typically 14 days). ]

Central Contacts and Locations

Central contacts

Daniel Renouf, MD, MPH

800-663-3333drenouf@bccancer.bc.ca

Locations

British Columbia Cancer

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Daniel Renouf, MD, MPH

800-663-3333drenouf@bccancer.bc.ca

Principal Investigator:

Daniel Renouf, MD, MPH

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Erica Tsang, MD, MPH

416-946-2000erica.tsang@uhn.ca

Robert Grant, MD

416-946-2000robert.grant@uhn.ca

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

  • FOLFIRINOX
  • Continuous Glucose Monitor
  • Feasibility
  • Glycemic management
  • Endocrinologist
  • Intensive glucose intervention
  • Pilot
  • Glucose control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2025-09-22.