Monitoring and Managing Glucose Levels in People With Pancreatic Cancer

NCT05132244 | Recruiting

• 1 other identifier: H21-03061
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Frequency of glucose levels maintained within range in Arm 1 compared to Arm 2

  The percentage of time each participant's glucose levels in Arm 1 and Arm 2 remained within the 4-10 mmol/L range during the fourth cycle of FOLFIRINOX treatment as measured by a continuous glucose monitor.

  From the Cycle 4 FOLFIRINOX treatment date to the Cycle 5 FOLFIRINOX treatment date (each cycle is typically 14 days).

Secondary Outcomes (3)

• Overall response rate (ORR) in each study arm, as defined by RECIST 1.1

  From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.

• Progression-free survival (PFS) in each study arm from the initiation of FOLFIRINOX

  From the date of first dose of FOLFIRINOX until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.

• Overall survival (OS) in each study arm from the initiation of FOLFIRINOX

  From the date of first dose of FOLFIRINOX until the date of death or end of study, whichever comes first, assessed up to 43 months.

Other Outcomes (10)

• Overall response rate (ORR) in each study arm, as defined by RECIST 1.1 and stratified by prognostic and metabolic gene expression subtypes of PDAC

  From the date of the screening scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.

• Progression-free survival (PFS) in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC from the initiation of FOLFIRINOX

  From the date of first dose of FOLFIRINOX until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 43 months.

• Overall survival (OS) in each study arm stratified by prognostic and metabolic gene expression subtypes of PDAC from the initiation of FOLFIRINOX

  From the date of first dose of FOLFIRINOX until the date of death or end of study, whichever comes first, assessed up to 43 months.

Study Arms (2)

Intensive Glucose Intervention

EXPERIMENTAL

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.

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

Standard Care

OTHER

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.

Other: Standard Care

Interventions

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

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.

Intensive Glucose Intervention

Standard Care OTHER

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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9/L.
• Platelet count greater than or equal to 75 x 10\^9/L.
• Hemoglobin greater than or equal to 9.0 g/dL.
• Estimated glomerular filtration rate (GFR) by Cockroft-Gault equation OR 24 hour urine collection greater than or equal to 40 ml/min.
• Creatinine clearance greater than or equal to 40 mL/min using Cockcroft-Gault formula.
• Potassium within normal limits, or corrected with supplements.
• International normalized ratio (INR) less than or equal to 1.5.
• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• University of British Columbia: collaborator
• Lustgarten Foundation: collaborator
• University Health Network, Toronto: collaborator

Study Sites (2)

British Columbia Cancer

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

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MeSH Terms

Conditions

Pancreatic Neoplasms; Hyperglycemia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Daniel Renouf, MD, MPH

  BC Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Renouf, MD, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants in Group 1 can view their glucose data in real-time from the continuous glucose monitor (CGM) whereas participants in Group 2 cannot. Participants in Groups 1 and 2 will NOT be masked to the anti-cancer or anti-hyperglycemic treatment they receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 24, 2021
• Study Start: April 16, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)