Pioglitazone Therapy Targeting Fatigue in Breast Cancer

Launched by WEST VIRGINIA UNIVERSITY · Aug 18, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called pioglitazone (often used to treat diabetes) to see if it can help reduce muscle fatigue in women with breast cancer. Fatigue is a common and challenging symptom for cancer patients, and this study aims to understand if pioglitazone can improve energy levels by targeting specific pathways in muscle cells. Currently, the trial is recruiting women aged 65 to 74 who have a specific type of breast cancer and who are planning to have surgery within two weeks of starting treatment.

To join the study, participants must have been diagnosed with a certain type of breast cancer (luminal type), and they should not have received other treatments apart from chemotherapy before surgery. They also need to meet certain health criteria, such as having normal blood tests and not having diabetes. Participants will take pioglitazone daily and will be monitored throughout the trial. It's important to note that women who are pregnant or breastfeeding cannot participate due to potential risks. This trial is a step toward finding new ways to help manage fatigue in breast cancer patients, and those interested should talk to their healthcare provider for more information.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Subjects must have histologically or cytologically confirmed luminal (ER+/PR+ Her2/neu-) Breast Cancer.
• • Subjects must have received no prior therapies besides chemotherapy in the neoadjuvant setting.
• • Subject must have a planned surgical (mastectomy) date within 2 weeks of starting treatment.
• * 5 Subjects must have normal organ as defined below:
• • Hemoglobin within normal institutional limits (or \>10?)
• • Fasting Blood Glucose within normal institutional limits
• • Serum Creatinine within normal institutional limits
• • Liver Function (AST and ALT, Alk phosphatase, Total Bilirubin) within normal limits
• • Subject does not have a prior diagnosis of diabetes or currently taking any medications to lower blood glucose levels.
• • Subjects must have the ability to understand and the willingness to sign a written informed consent document.
• Exclusion Criteria:
• • Prior diagnosis of Congestive Heart Failure (CHF), Bladder cancer, osteoporosis, bariatric surgery
• • Subjects receiving any other investigational agents or known agents to have a major interaction with PIO to include clopidogrel, gatifloxacin, gemfibrozil, leflunomide, lomitapide, lumateperone, mipomersen, pexideartinib and teriflunomide, insulin, Lyrica, Synthroid.
• • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pioglitazone.
• • Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, active alcoholism or psychiatric illness/social situations that would limit compliance with study requirements.
• • Pregnant or breastfeeding are excluded from this study because Pioglitazone has the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with PIO, breastfeeding should be discontinued if the mother is treated with PIO. These potential risks may also apply to other agents used in this study.