Pioglitazone Therapy Targeting Fatigue in Breast Cancer

Who is this study for? Patients with breast cancer
What treatments are being studied? Pioglitazone
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 5 Subjects must have normal organ as defined below:

‣ Hemoglobin within normal institutional limits (or \>10?)

⁃ Fasting Blood Glucose within normal institutional limits

⁃ Serum Creatinine within normal institutional limits

⁃ Liver Function (AST and ALT, Alk phosphatase, Total Bilirubin) within normal limits

• Subject does not have a prior diagnosis of diabetes or currently taking any medications to lower blood glucose levels.

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

Locations
United States
West Virginia
West Virginia University Cancer Institute
RECRUITING
Morgantown
Contact Information
Primary
Kristin Lupinacci, DO
kristin.lupinacci@hsc.wvu.edu
3042931022
Backup
Emidio Pistilli, PhD
epistilli2@hsc.wvu.edu
304-293-0291
Time Frame
Start Date: 2021-12-23
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
Active_comparator: Pioglitazone 15mg Dose
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.
Active_comparator: Pioglitazone 30mg Dose
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.
No_intervention: No Drug
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.
Related Therapeutic Areas
Sponsors
Leads: West Virginia University

This content was sourced from clinicaltrials.gov