Managing glucose levels in pancreatic cancer patients

Pancreatic Cancer Glucose Assessment and Regulation Study

This study is testing if closely managing blood sugar levels can help people with pancreatic cancer who are receiving standard chemotherapy feel better and improve their treatment outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: British Columbia Cancer Agency (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Vancouver, British Columbia and 1 other locations)
• Trial ID: NCT05132244 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of pancreatic ductal adenocarcinoma who are set to begin first-line systemic therapy with FOLFIRINOX.

Not a fit: Patients with other types of cancer or those not eligible for FOLFIRINOX treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and quality of life for patients with pancreatic cancer by better managing their glucose levels.

How similar studies have performed: While this approach is novel in the context of pancreatic cancer, similar studies in other cancer types have shown promising results in managing glucose levels.

Eligibility criteria

Inclusion Criteria:

* Histological/cytological diagnosis of pancreatic ductal adenocarcinoma (PDAC).
* Planned to undergo first-line systemic therapy with FOLFIRINOX.
* 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 and has no contraindications to subcutaneous insulin injections.
* 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).
* Not fit for combination chemotherapy as judged by the study doctor.
* 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.
* Female 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 this trial is running

Vancouver, British Columbia and 1 other locations

• 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

Conditions Pancreatic Cancer; PDAC - Pancreatic Ductal Adenocarcinoma; Hyperglycemia; FOLFIRINOX; Continuous Glucose Monitor; Feasibility; Glycemic management; Endocrinologist