This phase I trial studies whether applying minoxidil to the breast skin (topical) before surgery (preoperative) can be used to improve blood flow to breast tissue (flap perfusion) in patients undergoing preventative (prophylactic) surgery to remove both breasts and rebuild the shape of the breast (bilateral mastectomy and breast reconstruction). One of the most common complications of bilateral mastectomy and breast reconstruction is skin flap necrosis or the death of the tissue that is used for the reconstruction of the breast. Increasing flap perfusion is critical in preventing skin flap necrosis. Topical minoxidil is mainly used as a treatment for hair loss. It is a vasodilator, which means that it works by increasing the blood flow to areas where it is applied. Researchers think they may also be able to use topical minoxidil preoperatively to improve flap perfusion in patients undergoing prophylactic bilateral mastectomy and breast reconstruction.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07264790.
Locations matching your search criteria
United States
North Carolina
Durham
Duke University Medical CenterStatus: Active
Contact: Brett T. Phillips
Phone: 919-684-5237
PRIMARY OBJECTIVES:
I. Evaluate study feasibility: recruitment, retention, adherence, outcome measures.
II. Assess preliminary efficacy of topical minoxidil as a pharmacologic delay agent.
III. Assess preoperative and intraoperative flap perfusion using indocyanine green angiography (SPY-QP) technology.
IV. Analyze clinical outcomes related to flap perfusion.
OUTLINE: Patient's are randomized to 1 of 2 groups.
GROUP I: Patients apply minoxidil topically to the left breast once daily (QD) and placebo topically to the right breast QD for 2 weeks prior to scheduled surgery in the absence of unacceptable toxicity. Patients also undergo SPY-QP angiography on study.
GROUP II: Patients apply placebo topically to the left breast QD and minoxidil topically to the right breast QD for 2 weeks prior to scheduled surgery in the absence of unacceptable toxicity. Patients also undergo SPY-QP angiography on study.
After completion of study treatment, patients are followed up for 6 months.
Trial PhasePhase I
Trial Typesupportive care
Lead OrganizationDuke University Medical Center
Principal InvestigatorBrett T. Phillips
