Managing glucose levels in pancreatic cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study investigates the feasibility of closely monitoring and managing glucose levels in individuals diagnosed with pancreatic cancer. Approximately 50 participants will be treated with standard chemotherapy (FOLFIRINOX) while using continuous glucose monitors (CGM) to track their glucose levels. Participants will be randomly assigned to two groups: one receiving endocrinologist-directed treatment to maintain glucose levels between 4 and 10 mmol/L, and the other receiving standard care for glucose levels above 15 mmol/L. The study aims to assess the impact of glucose management on the overall treatment of pancreatic cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histological/cytological diagnosis of pancreatic ductal adenocarcinoma (PDAC).
* Planned to undergo first-line systemic therapy.
* 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:

  1. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9/L.
  2. Platelet count greater than or equal to 75 x 10\^9/L.
  3. Hemoglobin greater than or equal to 9.0 g/dL.
  4. Estimated glomerular filtration rate (GFR) by Cockroft-Gault equation OR 24 hour urine collection greater than or equal to 40 ml/min.
  5. Creatinine clearance greater than or equal to 40 mL/min using Cockcroft-Gault formula.
  6. Potassium within normal limits, or corrected with supplements.
  7. International normalized ratio (INR) less than or equal to 1.5.
  8. 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).
  9. 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.
* Able to comply with the study visit schedule and other protocol requirements.
* Able to swallow oral medications.
* Measurable or evaluable disease by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 at baseline.
* Life expectancy of more than 90 days as judged by the study doctor.

Exclusion Criteria:

* 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).
* 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.
* 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.

Where it's running

• British Columbia Cancer
  Vancouver, British Columbia, Canada Recruiting
• Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Daniel Renouf, MD, MPH — BC Cancer
• Study coordinator: Daniel Renouf, MD, MPH
• Email: drenouf@bccancer.bc.ca
• Phone: 800-663-3333

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.