Pioglitazone Therapy Targeting Fatigue in Breast Cancer

NCT05013255 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2103254164
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Muscle Fatigue

Outcome Measures

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.

  Up to 6 weeks

Secondary Outcomes (2)

• Muscle Fatigue

  Up to 6 weeks

• Body Weight

  2 weeks

Study Arms (3)

Pioglitazone 15mg Dose

ACTIVE COMPARATOR

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.

Drug: Pioglitazone 15mg

Pioglitazone 30mg Dose

ACTIVE COMPARATOR

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.

Drug: Pioglitazone 30 mg

No Drug

NO 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.

Interventions

Pioglitazone 15mg DRUG

PIO 15mg orally once daily for 2 weeks

Also known as: Actos

Pioglitazone 15mg Dose

Pioglitazone 30 mg DRUG

PIO 30mg orally once daily for 2 weeks

Also known as: Actos

Pioglitazone 30mg Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Pregnant or breastfeeding are excluded from this study because Pioglitazone has the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with PIO, breastfeeding should be discontinued if the mother is treated with PIO. These potential risks may also apply to other agents used in this study.

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University Cancer Institute

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kristin H Lupinacci, DO

  West Virginia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Lupinacci, DO

CONTACT

3042931022; kristin.lupinacci@hsc.wvu.edu

Emidio Pistilli, PhD

CONTACT

304-293-0291; epistilli2@hsc.wvu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 19, 2021
• Study Start: December 23, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

US (1)