Actively Recruiting
Pioglitazone Therapy Targeting Fatigue in Breast Cancer
Led by West Virginia University · Updated on 2025-04-08
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the potential of pioglitazone to address muscle fatigue in patients with breast cancer. Fatigue is common in these patients even before treatment and can worsen with therapies like chemotherapy and surgery. This Phase 2B trial focuses on determining the lowest effective dose of pioglitazone to improve muscle gene expression related to fatigue in breast cancer patients without diabetes. Participants will be randomly assigned to one of three groups: a low dose pioglitazone group (15mg daily), a high dose pioglitazone group (30mg daily), or a no-drug control group. The treatment lasts for 2 weeks, during which participants take the study drug orally once a day. This period leads up to a scheduled mastectomy, after which muscle biopsy samples will be collected. Following surgery, participants are monitored for 30 days for adverse events, fatigue levels, and body composition. Throughout the study, researchers will assess muscle gene expression changes up to 6 weeks, patient-reported fatigue, and body weight. Participants will have regular follow-up visits including post-operative assessments. The total participation lasts about 6 weeks, covering the treatment period and follow-up to evaluate the effects of pioglitazone on muscle fatigue and related biological markers.
CONDITIONS
Brief Title
Pioglitazone Therapy Targeting Fatigue in Breast Cancer
Who Can Participate
Eligibility Criteria
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 within 2 weeks of starting treatment
- Normal organ function including hemoglobin, fasting blood glucose, serum creatinine, and liver function tests
- No prior diagnosis of diabetes and not currently taking glucose-lowering medications
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior diagnosis of congestive heart failure, bladder cancer, osteoporosis, or history of bariatric surgery
- Receiving other investigational agents or drugs known to interact with pioglitazone
- History of allergic reactions to pioglitazone or similar compounds
- Uncontrolled illness such as active infection, unstable angina, cardiac arrhythmia, active alcoholism, or psychiatric/social issues limiting compliance
- Pregnant or breastfeeding women due to potential risks of pioglitazone
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants take daily pioglitazone at either a low dose (15mg) or high dose (30mg), or receive no drug, for 2 weeks leading up to their scheduled mastectomy.
1 baseline visit and surgery visit
Duration - 4 weeks
Participants are monitored for adverse events, fatigue, and body composition for 30 days following surgery through their first post-operative visit.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
West Virginia University Cancer Institute
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
K
Kristin Lupinacci, DO
E
Emidio Pistilli, PhD
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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