Evaluating Pioglitazone to Reduce Muscle Fatigue in Women with Breast Cancer A Phase 2 Study of Low and High Dose Pioglitazone Before Mastectomy

What this Trial Is About

Researchers are evaluating the potential of pioglitazone to address muscle fatigue in patients with breast cancer. Fatigue is common in these patients even before treatment and can worsen with therapies like chemotherapy and surgery. This Phase 2B trial focuses on determining the lowest effective dose of pioglitazone to improve muscle gene expression related to fatigue in breast cancer patients without diabetes. Participants will be randomly assigned to one of three groups a low dose pioglitazone group 15mg daily, a high dose pioglitazone group 30mg daily, or a no-drug control group. The treatment lasts for 2 weeks, during which participants take the study drug orally once a day. This period leads up to a scheduled mastectomy, after which muscle biopsy samples will be collected. Following surgery, participants are monitored for 30 days for adverse events, fatigue levels, and body composition. Throughout the study, researchers will assess muscle gene expression changes up to 6 weeks, patient-reported fatigue, and body weight. Participants will have regular follow-up visits including post-operative assessments. The total participation lasts about 6 weeks, covering the treatment period and follow-up to evaluate the effects of pioglitazone on muscle fatigue and related biological markers.

Pioglitazone Therapy Targeting Fatigue in Breast Cancer