Pioglitazone to Manage High Blood Sugar in Breast Cancer Patients on Alpelisib
Tests pioglitazone for high blood sugar in adults with breast cancer taking alpelisib.
Plain-language title generated from the registry record
Registry title: A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
Key facts
- Where
- Haifa, IsraelSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT05753657, who can take part
Where in Israel
- Rambam Health Care CampusHaifa, IsraelTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rambam Health Care Campus
- Trial code
- NCT05753657
- Record updated
- 3 March 2023
- Original description
The goal of this study is to test whether monitoring insulin levels and using pioglitazone to treat hyperglycemia and hyperinsulinemia in patients treated with Alpelisib for metastatic breast cancer is feasible and safe, and to assess the rates of glycemic control, dose reductions and treatment discontinuation and the progression free survival of patients treated with this regimen.Read full original descriptionShow less
A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
The goal of this study is to test whether monitoring insulin levels and using pioglitazone to treat hyperglycemia and hyperinsulinemia in patients treated with Alpelisib for metastatic breast cancer is feasible and safe, and to assess the rates of glycemic control, dose reductions and treatment discontinuation and the progression free survival of patients treated with this regimen.
Inclusion: Patients with ER positive HER2 negative metastatic breast cancer, harboring an activating PIK3CA mutation, scheduled to start treatment with Alpelisib and fulvestrant; Ages 18 - 85; ECOG performance status 0, 1 or 2; Ability to understand and willingness to sign a written informed consent.
Exclusion: Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Alpelisib; Diabetes mellitus controlled by insulin; Uncontrolled intercurrent illness including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; Known allergy to pioglitazone; Uncontrolled diabetes mellitus, defined as HbA1c above 8%; Pregnancy.