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Trial Title:
Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib
NCT ID:
NCT06083038
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Hyperglycemia
Conditions: Keywords:
Hyperglycemia
Glucose management
Alpelisib
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Alpelisib
Description:
Patients will receive standard of care alpelisib
Arm group label:
Metastatic breast cancer starting alpelisib
Intervention type:
Device
Intervention name:
FreeStyle Libre 2 Continuous Glucose Monitor
Description:
All patients will wear Abbott FreeStyle Libre 2 system to obtain CGM data (glucoses
measured every minute for 14 days). CGM monitors will be placed at least 10 days prior to
starting alpelisib and continue CGM for at least 3 months while taking alpelisib.
Arm group label:
Metastatic breast cancer starting alpelisib
Summary:
This is a prospective, descriptive, single site, observational study in subjects
receiving alpelisib for treatment of metastatic breast cancer. The purpose of the study
is to characterize the impact of alpelisib on glucose control in patients with breast
cancer using continuous glucose monitoring to measure glucose levels throughout the day
and night. Patients will follow a hyperglycemia prevention and management regimen aimed
to diminish hyperglycemia known to occur in most oncology patients starting alpelisib.
All patients will wear an Abbott FreeStyle Libre 2 system to obtain continuous glucose
monitor (CGM) data (glucose measured every minute for 14 days). CGM will be placed at
least 10 days prior to starting alpelisib and continue for at least 3 months while taking
alpelisib.
Criteria for eligibility:
Study pop:
Subjects scheduled to receive standard of care alpelisib for treatment of metastatic
breast cancer.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Adults aged 18 or older with a diagnosis of metastatic breast cancer that are
initiating treatment with alpelisib.
2. Must be willing and able to comply with study visits and procedures.
3. Must meet standard clinical criteria for utilization of alpelisib including
hormone-receptor positive/HER2 negative cancer with the presence of a PIK3CA
mutation.
4. Oncologist plans to use alpelisib until progression of disease or unacceptable
toxicity.
5. Patients must receive cancer care during alpelisib treatment phase with a
HealthPartners oncologist and be willing to see IDC/HealthPartners Diabetes
Education for diabetes management.
6. Must have a compatible smartphone, access to a compatible smartphone, or the ability
to upload CGM reader from home or bring the reader in to a medical visit at least
once a month for uploading, to allow for remote management of diabetes and data
collection.
7. Life expectancy of at least 3 months
Exclusion Criteria:
1. Known history of serious allergy to skin-adhesive material or previous cutaneous
reaction to a continuous glucose monitor.
2. Known currently uncontrolled diabetes, defined as the most recent HbA1c over 10% or
history of DKA within 6 months prior to enrollment.
3. Concurrent use of high-dose vitamin C, defined as ≥ 1g of oral vitamin C daily, or
intravenous Vitamin C infusions.
4. Any other concurrent severe and/or uncontrolled medical condition that, in the
opinion of the investigator, would cause unacceptable safety risk, compromise
compliance with the protocol, or contraindicate participation in the study. One
example being known requirement for high dose steroids at the time of possible
enrollment into the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
HealthPartners Cancer Research Center
Address:
City:
Saint Louis Park
Zip:
55426
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jordan Cowger
Phone:
952-993-6071
Email:
jordan.cowger@parknicollet.com
Investigator:
Last name:
Dylan Zylla, MD
Email:
Principal Investigator
Investigator:
Last name:
Richard Bergenstal, MD
Email:
Sub-Investigator
Investigator:
Last name:
Molly Carlson, MD
Email:
Sub-Investigator
Start date:
October 5, 2023
Completion date:
June 1, 2025
Lead sponsor:
Agency:
HealthPartners Institute
Agency class:
Other
Source:
HealthPartners Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06083038
