RECRUITING

Pioglitazone Therapy Targeting Fatigue in Breast Cancer

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Conditions

Breast CancerMuscle Fatigue

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pioglitazone Therapy Targeting Fatigue in Breast Cancer

Quick Facts

Study Start:2021-12-23
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05013255

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects must have histologically or cytologically confirmed luminal (ER+/PR+ Her2/neu-) Breast Cancer.
  2. * Subjects must have received no prior therapies besides chemotherapy in the neoadjuvant setting.
  3. * Subject must have a planned surgical (mastectomy) date within 2 weeks of starting treatment.
  4. * 5 Subjects must have normal organ as defined below:
  5. * Hemoglobin within normal institutional limits (or \>10?)
  6. * Fasting Blood Glucose within normal institutional limits
  7. * Serum Creatinine within normal institutional limits
  8. * Liver Function (AST and ALT, Alk phosphatase, Total Bilirubin) within normal limits
  9. * Subject does not have a prior diagnosis of diabetes or currently taking any medications to lower blood glucose levels.
  10. * Subjects must have the ability to understand and the willingness to sign a written informed consent document.
  1. * Prior diagnosis of Congestive Heart Failure (CHF), Bladder cancer, osteoporosis, bariatric surgery
  2. * 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.
  3. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pioglitazone.
  4. * 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.
  5. * 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.

Contacts and Locations

Study Contact

Kristin Lupinacci, DO
CONTACT
3042931022
kristin.lupinacci@hsc.wvu.edu
Emidio Pistilli, PhD
CONTACT
304-293-0291
epistilli2@hsc.wvu.edu

Principal Investigator

Kristin H Lupinacci, DO
PRINCIPAL_INVESTIGATOR
West Virginia University

Study Locations (Sites)

West Virginia University Cancer Institute
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: West Virginia University

  • Kristin H Lupinacci, DO, PRINCIPAL_INVESTIGATOR, West Virginia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-23
Study Completion Date2026-12

Study Record Updates

Study Start Date2021-12-23
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer
  • Muscle Fatigue