Pioglitazone Therapy Targeting Fatigue in Breast Cancer

Part of paid clinical trials in Morgantown, West Virginia.

Sponsor
West Virginia University
Study ID
NCT05013255
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pioglitazone 15mg — DRUG
    PIO 15mg orally once daily for 2 weeks
  • Pioglitazone 30 mg — DRUG
    PIO 30mg orally once daily for 2 weeks

Study Details

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.

Key Dates

Start date
Dec 23, 2021
Status verified
Apr 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Muscle Gene Expression [ Time Frame: Up to 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
West Virginia University Cancer InstituteMorgantownWest Virginia26506
Kristin Lupinacci, DO
[email protected]
304-293-1022

Find similar trials in Morgantown, WV

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
West Virginia University Cancer Institute· Morgantown, WV

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