Using pioglitazone to reduce fatigue in breast cancer patients
Pioglitazone Therapy Targeting Fatigue in Breast Cancer
This study is testing if the diabetes drug pioglitazone can help reduce muscle fatigue in breast cancer patients who haven't started treatment yet.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | West Virginia University Academic / other |
| Drugs / interventions | pexideartinib, chemotherapy, radiation |
| Locations | 1 site (Morgantown, West Virginia) |
| Trial ID | NCT05013255 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women with confirmed luminal breast cancer who have not received prior therapies other than neoadjuvant chemotherapy.
Not a fit: Patients with a prior diagnosis of diabetes or those currently taking medications to lower blood glucose levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for breast cancer patients suffering from fatigue.
How similar studies have performed: While pioglitazone is an established treatment for diabetes, its application for muscle fatigue in cancer patients is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Morgantown, West Virginia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.