RecruitingPhase 2NCT05013255

Pioglitazone Therapy Targeting Fatigue in Breast Cancer

Sponsor

West Virginia University

Enrollment

30 participants

Start Date

Dec 23, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Muscle Fatigue

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria10

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.
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 Criteria5

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.