This phase II trial tests the willingness of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized study of NSM with or without neurotization of the nipple areolar complex (NAC). This trial also compares patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization of the NAC. NSM is a standard practice option for patients undergoing preventative mastectomy, but many report dissatisfaction with decreased nipple sensation. Neurotization is a surgical technique using a nerve graft in an attempt to restore NAC sensation. Neurotization during NSM and reconstruction may restore NAC sensation and improve quality of life in breast cancer patients.
Additional locations may be listed on ClinicalTrials.gov for NCT06153836.
Locations matching your search criteria
United States
Florida
Jacksonville
Mayo Clinic in FloridaStatus: Active
Contact: James Ward Jakub
Phone: 904-953-2000
PRIMARY OBJECTIVE:
I. To determine willingness of patients undergoing NSM to enroll in a randomized trial of NSM with or without neurotization.
SECONDARY OBJECTIVES:
I. To compare patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization.
II. To compare NAC sensation at 12 months in patients undergoing NSM with or without neurotization.
III To determine rate of mastectomy skin flap necrosis following NSM via the skin ischemia and necrosis (SKIN) score.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care NSM on study.
ARM II: Patients undergo neurotization during standard of care NSM on study.
After completion of study intervention, patients are followed at 14 days and at 6, 12 and 24 months postoperatively.
Lead OrganizationMayo Clinic in Florida
Principal InvestigatorJames Ward Jakub
