Recruiting
Phase 2

Pioglitazone

Sponsor:

West Virginia University

Code:

NCT05013255

Conditions

Breast Cancer

Muscle Fatigue

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pioglitazone 15mg

Pioglitazone 30 mg

Study Details

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.

Conditions

Breast Cancer

Muscle Fatigue

Study ID

NCT05013255

Start date

Dec 23, 2021

Status verified date

Apr, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pioglitazone 15mg Dose

Subjects will be given PIO 15mg once daily, based on the randomization lists prepared by the WVUCI Biostatistics Core. This is a 1:1:1 randomization (10 in each group) without any planned stratification.

active comparator: Pioglitazone 30mg Dose

Subjects will be given PIO 30mg once daily, based on the randomization lists prepared by the WVUCI Biostatistics Core. This is a 1:1:1 randomization (10 in each group) without any planned stratification.

no intervention: No Drug

Subjects will be assigned to a no drug control group based on the randomization lists prepared by the WVUCI Biostatistics Core. This is a 1:1:1 randomization (10 in each group) without any planned stratification.

Interventions

Pioglitazone 15mg

PIO 15mg orally once daily for 2 weeks

Pioglitazone 30 mg

PIO 30mg orally once daily for 2 weeks

Primary outcome measure

  • Muscle Gene Expression [ Time Frame: Up to 6 weeks ]

Central Contacts and Locations

Central contacts

Kristin Lupinacci, DO

3042931022kristin.lupinacci@hsc.wvu.edu

Emidio Pistilli, PhD

304-293-0291epistilli2@hsc.wvu.edu

Locations

West Virginia University Cancer Institute

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Kristin Lupinacci, DO

304-293-1022kristin.lupinacci@hsc.wvu.edu

More Information

Sponsor

West Virginia University

Last update posted

Apr 8, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by West Virginia University on 2025-04-08.