NCT05013255 Pioglitazone Therapy Targeting Fatigue in Breast Cancer
| NCT ID | NCT05013255 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | West Virginia University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-12-23 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2021-12-23 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this project is to evaluate the therapeutic potential of pioglitazone (PIO) to target underlying mechanisms that promote muscle fatigue in patients with breast cancer. This represents an off-label use of this compound, both in terms of the patient population and the clinical phenotype targeted. The central research hypothesis of this study is that daily pioglitazone will restore transcriptional downregulation of pathways within skeletal that promote fatigue.
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.
Contact & Investigator
Kristin H Lupinacci, DO
PRINCIPAL INVESTIGATOR
West Virginia University
Frequently Asked Questions
Who can join the NCT05013255 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05013255 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05013255 currently recruiting?
Yes, NCT05013255 is actively recruiting participants. Contact the research team at kristin.lupinacci@hsc.wvu.edu for enrollment information.
Where is the NCT05013255 trial being conducted?
This trial is being conducted at Morgantown, United States.
Who is sponsoring the NCT05013255 clinical trial?
NCT05013255 is sponsored by West Virginia University. The principal investigator is Kristin H Lupinacci, DO at West Virginia University. The trial plans to enroll 30 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.