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Pioglitazone Therapy Targeting Fatigue in Breast Cancer

ConditionsBreast CancerMuscle Fatigue
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Pioglitazone 15mg

    Drug

    PIO 15mg orally once daily for 2 weeks

  • Pioglitazone 30 mg

    Drug

    PIO 30mg orally once daily for 2 weeks

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Pioglitazone 15mg DoseActive comparator 1 intervention
Group B: Pioglitazone 30mg DoseActive comparator 1 intervention
Group C: No DrugNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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 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.

Time frame
Up to 6 weeks

Secondary outcomes

1

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.

Time frame
Up to 6 weeks
2

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

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West Virginia University

Lead sponsor

Source ClinicalTrials.gov
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