Using pioglitazone to reduce fatigue in breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to evaluate the effectiveness of pioglitazone, a drug typically used for diabetes, in alleviating muscle fatigue in patients with breast cancer. The study focuses on understanding how pioglitazone can restore pathways in skeletal muscle that contribute to fatigue, particularly in patients who have not yet undergone treatment. Participants will receive either 15mg or 30mg of pioglitazone daily, and the study will gather data on optimal dosing to inform future larger trials. The research addresses a significant gap in treatment options for cancer-related fatigue, which is often debilitating and poorly managed.

Why it matters

Who can join: the full rules

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.

Where it's running

• West Virginia University Cancer Institute
  Morgantown, West Virginia, United States Recruiting

Study contacts

• Principal investigator: Kristin H Lupinacci, DO — West Virginia University
• Study coordinator: Kristin Lupinacci, DO
• Email: kristin.lupinacci@hsc.wvu.edu
• Phone: 3042931022

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.