Breast Cancer Clinical Trial
Official title:
Pioglitazone Therapy Targeting Fatigue in Breast Cancer
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | April 2023 |
Est. primary completion date | April 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | West Virginia University Cancer Institute | Morgantown | West Virginia |
Lead Sponsor | Collaborator |
---|---|
West Virginia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Muscle Gene Expression | 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 PPAR? 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. | Up to 6 weeks | |
Secondary | Muscle Fatigue | Assess the fatigue in subjects with breast cancer that are being treated with pioglitazone, as measured by the FACT-F questionnaire. 5 point Likert-type scale where 0= Not at all, 1= A little bit, 2= Somewhat, 3= Quite a bit, 4= Very much. | Up to 6 weeks | |
Secondary | Body Weight | Monitor body weight for loss or gains in subjects receiving low dose and high dose pioglitazone for 2 weeks prior to a scheduled mastectomy | 2 weeks |
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