No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
British Columbia Cancer Agency · Other
Who this trial is looking for
This trial is looking for people with pancreatic cancer who are starting treatment. Participants will have their blood sugar closely monitored and managed while receiving chemotherapy.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with pancreatic ductal adenocarcinoma.
I am starting first-line treatment with FOLFIRINOX.
I am 18 years or older.
I am able to understand and sign the consent form.
I can take oral medications and have no issues with insulin injections.
I have measurable or evaluable cancer.
My life expectancy is more than 90 days.
You may not be able to join if
I do not have distant or lymph node metastases.
I have not received prior systemic therapy for metastatic pancreatic cancer.
I am not currently receiving any anti-cancer therapy.
I do not have brain metastases.
I do not have type I diabetes.
I do not have type II diabetes being treated by an endocrinologist.
I am not pregnant.
I am safe to include in the study as judged by the study doctor.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study will investigate the prevalence of hyperglycemia (high blood sugar) in approximately 50 participants with pancreatic cancer. Sugar levels will be monitored with blood draws prior to each cycle of anti-cancer treatment until treatment ends or the participant's cancer worsens. Participants may receive any first-line systemic therapy for pancreatic cancer, including treatments given as par…
This study will investigate the prevalence of hyperglycemia (high blood sugar) in approximately 50 participants with pancreatic cancer. Sugar levels will be monitored with blood draws prior to each cycle of anti-cancer treatment until treatment ends or the participant's cancer worsens. Participants may receive any first-line systemic therapy for pancreatic cancer, including treatments given as part of another clinical trial. If treatment is needed to manage blood sugar levels, the treatment will be given according to the standard of care. All participants will be enrolled into the same group.
Trial Locations
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Status
Eligibility Criteria
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 functi…
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.
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