Obesity related hyperinsulinaemia and hyperglycaemia and cancer development.
Susen Becker, Laure Dossus, Rudolf Kaaks
https://pubmed.ncbi.nlm.nih.gov/19485704Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05132244
Pancreatic Cancer Glucose Assessment and Regulation Study Monitoring and Managing Glucose Levels in People With Pancreatic Cancer
Led by British Columbia Cancer Agency · Updated on 2025-09-22
50
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
B
British Columbia Cancer Agency
Lead Sponsor
U
University of British Columbia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether closely monitoring and managing blood sugar levels can be done effectively in people with pancreatic cancer and how this management might affect their condition. This pilot study involves about 50 participants diagnosed with pancreatic ductal adenocarcinoma (PDAC) who will receive standard chemotherapy called FOLFIRINOX. The study compares two approaches to controlling blood sugar during treatment by using continuous glucose monitors (CGM). Participants will be randomly assigned to one of two groups. Group 1 will receive anti-hyperglycemic treatment guided by an endocrinologist aiming to keep glucose levels between 4 and 10 mmol/L, using data from a CGM and regular blood tests. They will have real-time access to their glucose data. Group 2 will receive treatment only if blood sugar exceeds 15 mmol/L based on standard blood tests, which is the usual care approach. Both groups will receive standard anti-hyperglycemic medications such as metformin, insulin, GLP-1 receptor agonists, SGLT2 inhibitors, and DPP-4 inhibitors. After completing 4 chemotherapy cycles, the CGM will be removed but glucose treatments may continue if needed. Participants will be followed for survival and further cancer treatments as appropriate. During the study, participants will be monitored through regular blood tests before each chemotherapy cycle and continuous glucose monitoring. The study will track how often glucose levels stay within the target range in each group during treatment cycles. Researchers will also assess cancer response rates, progression-free survival, and overall survival over several months. Follow-up will continue for glucose management and cancer outcomes, with treatment adjustments made as advised by endocrinologists and oncologists. The total study duration may extend up to approximately 43 months for long-term assessment.
CONDITIONS
Brief Title
Monitoring and Managing Glucose Levels in People With Pancreatic Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histological or cytological diagnosis of pancreatic ductal adenocarcinoma (PDAC).
- Planned to start first-line systemic therapy with FOLFIRINOX.
- At least 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate bone marrow and organ function as shown by specific blood and kidney test results.
- Able to understand and voluntarily sign the informed consent form.
- Able to comply with study visits and protocol requirements.
- Able to swallow oral medications and tolerate subcutaneous insulin injections.
- Measurable or evaluable disease per RECIST 1.1 at baseline.
- Expected life expectancy of more than 90 days as judged by the study doctor.
You will not qualify if you...
- No distant or lymph node metastases; borderline resectable or locally advanced PDAC not eligible.
- Prior systemic therapy for metastatic PDAC; those who had adjuvant chemotherapy after surgery may participate.
- Currently receiving any anti-cancer therapy.
- Not fit for combination chemotherapy as judged by the study doctor.
- Presence of brain metastases.
- Known type I diabetes with strict glucose control and endocrinology follow-up.
- Known type II diabetes already managed by an endocrinologist.
- Positive pregnancy test for female participants.
- Deemed unsafe for study participation by the study doctor for medical or non-medical reasons.
- Unable to comply with study assessments and follow-up.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - Up to approximately 14-day cycles of chemotherapy (FOLFIRINOX), duration depends on treatment period
Participants receive anti-hyperglycemic treatment during chemotherapy cycles, either intensively managed by an endocrinologist using continuous glucose monitor data or standard care with treatment only if glucose is high.
Visits prior to each chemotherapy cycle for blood work and glucose monitoring
Follow-up
Duration - Up to 43 months after treatment initiation
Participants are monitored for overall response, progression-free survival, and overall survival up to 43 months after starting treatment.
Periodic visits for outcome assessments
Trial Site Locations
Total: 2 locations
1
British Columbia Cancer
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
2
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Loading map...
Research Team
D
Daniel Renouf, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
High-fat, high-calorie diet promotes early pancreatic neoplasia in the conditional KrasG12D mouse model.
David W Dawson, Kathleen Hertzer, Aune Moro...
https://pubmed.ncbi.nlm.nih.gov/23943783Glucocorticoid-induced hyperglycemia is prevalent and unpredictable for patients undergoing cancer therapy: an observational cohort study.
D Harris, A Barts, J Connors...
https://pubmed.ncbi.nlm.nih.gov/24311953Pancreatic cancer: a review of the evidence on causation.
Andrew R Hart, Hugh Kennedy, Ian Harvey
https://pubmed.ncbi.nlm.nih.gov/18328435Risk factors for pancreatic cancer: case-control study.
Manal M Hassan, Melissa L Bondy, Robert A Wolff...
https://pubmed.ncbi.nlm.nih.gov/17764494Obesity and diabetes epidemics: cancer repercussions.
Anette Hjartåker, Hilde Langseth, Elisabete Weiderpass
https://pubmed.ncbi.nlm.nih.gov/18637486Type-II diabetes and pancreatic cancer: a meta-analysis of 36 studies.
R Huxley, A Ansary-Moghaddam, A Berrington de González...
https://pubmed.ncbi.nlm.nih.gov/15886696Altered Gene Expression along the Glycolysis-Cholesterol Synthesis Axis Is Associated with Outcome in Pancreatic Cancer.
Joanna M Karasinska, James T Topham, Steve E Kalloger...
https://pubmed.ncbi.nlm.nih.gov/31481506Targeting metabolic reprogramming in KRAS-driven cancers.
Kenji Kawada, Kosuke Toda, Yoshiharu Sakai
https://pubmed.ncbi.nlm.nih.gov/28647837Early Detection of Pancreatic Cancer-a Defined Future Using Lessons From Other Cancers: A White Paper.
Barbara J Kenner, Suresh T Chari, Anirban Maitra...
https://pubmed.ncbi.nlm.nih.gov/27518362