What is this study trying to find out about pancreatic cancer?

This study is investigating whether closely monitoring and managing blood sugar levels can be done effectively in people with pancreatic cancer and how this might impact their cancer treatment. It compares two approaches to glucose control during chemotherapy. The research is sponsored by the British Columbia Cancer Agency. Participants can expect regular monitoring of their glucose levels and cancer response during the trial.

Who may be eligible for this pancreatic cancer clinical trial?

Adults aged 18 years or older with a diagnosis of pancreatic ductal adenocarcinoma who are planned to start first-line chemotherapy with FOLFIRINOX may be eligible. Participants must have good performance status and adequate organ function. People with brain metastases or currently receiving cancer treatment are not eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this pancreatic cancer clinical trial?

Study-related care, including chemotherapy, glucose monitoring, and all trial visits, is provided at no cost. Personal travel or other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05132244

Study of Glucose Monitoring and Management During Chemotherapy for Pancreatic Cancer

Led by British Columbia Cancer Agency · Updated on 2025-09-22

Participants Needed

Research Sites

N/A

Total Duration

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 mmolL, 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 mmolL 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.

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