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2024-04-16
2026-04
2027-04
50
NCT05132244
British Columbia Cancer Agency
British Columbia Cancer Agency
INTERVENTIONAL
Monitoring and Managing Glucose Levels in People With Pancreatic Cancer
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-11-10 | N/A | 2024-04-16 |
2021-11-22 | N/A | 2024-04-18 |
2021-11-24 | N/A | 2024-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| 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 ma | PROCEDURE: Endocrinologist-directed target blood glucose level 4-10 mmol/L using data from a continuous glucose monitor (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 | OTHER: Standard Care
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) in each study arm, as defined by RECIST 1.1 | The proportion of participants in each study arm who have a complete response (CR) or partial response (PR) to FOLFIRINOX treatment, 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 | The length of time from the first dose of FOLFIRINOX until the date of progressive disease (PD), as defined by RECIST 1.1, for participants in each study arm. | 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 | The length of time from the initiation of FOLFIRINOX that participants survive in each study arm. | 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. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Daniel Renouf, MD, MPH Phone Number: 604-877-6000 Email: drenouf@bccancer.bc.ca |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
