RecruitingNot ApplicableNCT05132244

Monitoring and Managing Glucose Levels in People With Pancreatic Cancer

Pancreatic Cancer Glucose Assessment and Regulation Study


Sponsor

British Columbia Cancer Agency

Enrollment

50 participants

Start Date

Apr 16, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study monitors and manages blood sugar levels in people with pancreatic cancer receiving chemotherapy, since high blood sugar can affect treatment outcomes. **You may be eligible if...** - You have been diagnosed with pancreatic ductal adenocarcinoma (the most common type of pancreatic cancer) - You are about to start first-line chemotherapy with FOLFIRINOX - You are 18 or older - You are in good overall health (ECOG 0–1) with adequate blood counts and organ function **You may NOT be eligible if...** - You are not starting FOLFIRINOX chemotherapy - You have poor blood counts or organ function that does not meet required thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndocrinologist-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.

OTHERStandard 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.


Locations(2)

British Columbia Cancer

Vancouver, British Columbia, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

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NCT05132244


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