Pioglitazone for Fatigue in Breast Cancer

Overseen By Emidio Pistilli, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: West Virginia University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

30 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Kristin H Lupinacci, DO

Principal Investigator

West Virginia University

Eligibility Criteria

This trial is for individuals with luminal breast cancer (ER+/PR+ Her2/neu-) who have not had any treatments other than chemotherapy. They must have normal organ function, no diabetes or medications affecting blood glucose, and a scheduled mastectomy within two weeks. Pregnant or breastfeeding women, those with heart failure, bladder cancer, osteoporosis, bariatric surgery history or certain illnesses are excluded.

Inclusion Criteria

Subjects must have the ability to understand and the willingness to sign a written informed consent document

I have never been diagnosed with diabetes nor take any blood sugar-lowering medications.

My mastectomy is scheduled within 2 weeks of starting treatment.

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pioglitazone

Subjects with uncontrolled intercurrent illness including ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, active alcoholism or psychiatric illness/social situations that would limit compliance with study requirements

I have had congestive heart failure, bladder cancer, osteoporosis, or bariatric surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive daily pioglitazone therapy for 2 weeks prior to scheduled mastectomy

2 weeks

1 visit (in-person) for drug dispensation

Surgery and Biopsy

Participants undergo mastectomy and muscle biopsy collection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events, fatigue, and body composition for 30 days post-surgery

4 weeks

1 visit (in-person) for follow-up assessment

Treatment Details

Interventions

• Pioglitazone

Trial Overview The study tests pioglitazone's ability to reduce muscle fatigue in breast cancer patients by adjusting gene activity in skeletal muscles. Participants will receive either 30 mg or 15 mg of pioglitazone daily in this off-label use case to see if it can alleviate fatigue symptoms.

Participant Groups

Group I: Pioglitazone 15mg Dose Active Control 1 Intervention

Subjects will be given PIO 15mg once daily, based on the randomization lists prepared by the WVUCI Biostatistics Core. This is a 1:1:1 randomization (10 in each group) without any planned stratification.

Group II: Pioglitazone 30mg Dose Active Control 1 Intervention

Subjects will be given PIO 30mg once daily, based on the randomization lists prepared by the WVUCI Biostatistics Core. This is a 1:1:1 randomization (10 in each group) without any planned stratification.

Group III: No Drug Active Control 1 Intervention

Subjects will be assigned to a no drug control group based on the randomization lists prepared by the WVUCI Biostatistics Core. This is a 1:1:1 randomization (10 in each group) without any planned stratification.

Pioglitazone is already approved in United States for the following indications:

Approved in United States as Actos for:

• Type 2 diabetes mellitus

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+