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New treatment option for Pancreatic Cancer
Official title Monitoring and Managing Glucose Levels in People With Pancreatic Cancer
ClinicalTrials.gov ID: NCT05132244
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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:
You likely can't join if
- 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...
- 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.
See the full eligibility 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:
- Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9/L.
- Platelet count greater than or equal to 75 x 10\^9/L.
- Hemoglobin greater than or equal to 9.0 g/dL.
- Estimated glomerular filtration rate (GFR) by Cockroft-Gault equation OR 24 hour urine collection greater than or equal to 40 ml/min.
- Creatinine clearance greater than or equal to 40 mL/min using Cockcroft-Gault formula.
- Potassium within normal limits, or corrected with supplements.
- International normalized ratio (INR) less than or equal to 1.5.
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.