No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
West Virginia University · Other
Who this trial is looking for
This trial is looking for women with certain types of breast cancer who are experiencing muscle fatigue. Participants will take a medication called pioglitazone daily to see if it helps improve their fatigue before surgery.
Are You a Good Fit for This Trial?
Must not be takingClopidogrelGatifloxacinGemfibrozilLeflunomideLomitapideLumateperone
You may be able to join if
I have confirmed luminal breast cancer.
I have not received any therapies other than chemotherapy before surgery.
I have a surgery date planned within the next 2 weeks.
I have normal blood levels as defined by the study.
I do not have diabetes.
I can understand and sign a consent form.
You may not be able to join if
I have been diagnosed with Congestive Heart Failure.
I have a history of bladder cancer.
I have osteoporosis.
I have had bariatric surgery.
I am taking any other investigational medications.
I have a history of allergic reactions to similar medications.
I have an uncontrolled illness or active infection.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 transc…
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.
Trial Locations
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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 …
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.
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