Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT05013255

Pioglitazone Therapy Targeting Fatigue in Breast Cancer

Led by West Virginia University · Updated on 2025-04-08

30

Participants Needed

1

Research Sites

257 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Pioglitazone Therapy Targeting Fatigue in Breast Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed luminal (ER+/PR+ Her2/neu-) breast cancer
  • No prior therapies except chemotherapy in the neoadjuvant setting
  • Planned mastectomy surgery within 2 weeks of starting treatment
  • Normal hemoglobin levels within institutional limits
  • Normal fasting blood glucose within institutional limits
  • Normal serum creatinine within institutional limits
  • Normal liver function tests (AST, ALT, alkaline phosphatase, total bilirubin) within limits
  • No prior diagnosis of diabetes or use of blood glucose-lowering medications
  • Ability to understand and willingness to sign informed consent
Not Eligible

You will not qualify if you...

  • Prior diagnosis of congestive heart failure, bladder cancer, osteoporosis, or history of bariatric surgery
  • Use of other investigational agents or drugs with major interactions with pioglitazone (e.g., clopidogrel, gatifloxacin, gemfibrozil, leflunomide, lomitapide, lumateperone, mipomersen, pexideartinib, teriflunomide, insulin, Lyrica, Synthroid)
  • History of allergic reactions to compounds similar to pioglitazone
  • Uncontrolled illnesses such as active infection, unstable angina, cardiac arrhythmia, active alcoholism, or psychiatric/social issues limiting compliance
  • Pregnant or breastfeeding women due to potential risks to infants

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

West Virginia University Cancer Institute

Morgantown, West Virginia, United States, 26506

Actively Recruiting

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Research Team

K

Kristin Lupinacci, DO

CONTACT

E

Emidio Pistilli, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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