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Pioglitazone for Fatigue in Breast Cancer

This study is looking at whether pioglitazone (PIO), a medication, can help reduce muscle fatigue in women with breast cancer. Fatigue is a common and often untreated problem for cancer patients. Researchers believe pioglitazone might work by changing how certain genes in your muscles behave. You could be eligible if you are a woman, 18 or older, have a specific type of breast cancer (luminal, meaning ER+/PR+ Her2/neu-), have not had prior treatments other than chemotherapy before surgery, and have surgery planned within two weeks. The study will test two different doses of pioglitazone (15mg or 30mg) taken daily for two weeks. The main goal is to see how pioglitazone affects gene expression in muscle tissue, which will help plan larger studies in the future. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 30 women. It will test two different doses of pioglitazone.
What's involved
Participants will take pioglitazone orally once daily for 2 weeks.
Compensation
Not stated in the trial record.
Follow-up
Muscle gene expression will be measured up to 6 weeks after starting treatment.

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NCT05013255

Pioglitazone Therapy Targeting Fatigue in Breast Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
West Virginia University
~30 participants
Updated 2025-04-08 on ClinicalTrials.gov
What's tested:Pioglitazone 15mgPioglitazone 30 mg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Muscle Gene Expression
Measured over Up to 6 weeks

Conditions

Breast Cancer
Muscle Fatigue

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
West Virginia1

Study leadership

  • Kristin H Lupinacci, DO · PRINCIPAL_INVESTIGATOR · West Virginia University

Who to contact

Kristin Lupinacci, DO
[email protected]
3042931022
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Muscle Gene ExpressionUp to 6 weeks

    evaluate the ability of daily pioglitazone therapy to attenuate the transcriptional downregulation of a gene network within skeletal muscle that is integral to mitochondrial bioenergetics, with PPARγ central to this network. The outcome measure will be RNA-Sequencing and gene expression analysis from muscle biopsies obtained from subjects following either low dose or high dose pioglitazone therapy.