RecruitingPhase 2NCT05013255

Pioglitazone Therapy Targeting Fatigue in Breast Cancer


Sponsor

West Virginia University

Enrollment

30 participants

Start Date

Dec 23, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether pioglitazone — a drug typically used for diabetes — can reduce cancer-related fatigue in women with a specific type of breast cancer (hormone receptor-positive, HER2-negative) who are about to have surgery. **You may be eligible if...** - You have been diagnosed with luminal breast cancer (estrogen and/or progesterone receptor-positive, HER2-negative) confirmed by biopsy - You have not had prior treatment other than neoadjuvant (pre-surgery) chemotherapy - You are scheduled to have a mastectomy within 2 weeks of starting treatment - Your blood counts, blood sugar, and organ function are within normal ranges **You may NOT be eligible if...** - You have HER2-positive breast cancer - You have had prior treatments other than neoadjuvant chemotherapy - You have diabetes or are already taking pioglitazone - Your surgery is not planned within the required timeframe - You have liver, kidney, or bone marrow problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPioglitazone 15mg

PIO 15mg orally once daily for 2 weeks

DRUGPioglitazone 30 mg

PIO 30mg orally once daily for 2 weeks


Locations(1)

West Virginia University Cancer Institute

Morgantown, West Virginia, United States

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NCT05013255


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