Pioglitazone Therapy Targeting Fatigue in Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWest Virginia University
About this trial
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 criteria
Qualifiers
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.
Hemoglobin within normal institutional limits (or >10?)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Pioglitazone 15mg
- Pioglitazone 30 mg
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov