This clinical trial tests how well breast neurotization works to promote the return of nipple sensation in patients undergoing nipple sparing mastectomy with bilateral implant-based breast reconstruction surgery. Following mastectomy, sensation to the breast and nipple areolar complex can be diminished or eliminated. While sensation may return to varying degrees, often post-mastectomy sensation is diminished from pre-mastectomy levels. Breast neurotization is the surgical procedure of helping restore sensation to the breast following a mastectomy. This procedure involves connecting the native nerves of the chest to the nipple through nerve grafts or nerve connectors in order to help facilitate nerve regrowth and sensation to the breast and nipple areolar complex. Undergoing breast neurotization may result in more nipple sensation in patients undergoing a mastectomy with breast reconstruction surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT05757778.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To assess the effect of breast neurotization following nipple-sparing mastectomy by comparing return of nipple sensation in the neurotized breast versus the untreated breast within the same patient.
SECONDARY OBJECTIVE:
I. To assess patient perception of breast reconstruction and quality of life following breast neurotization while assessing for perceived differences between the neurotized and non-neurotized breast.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo nipple sparing mastectomy with implant-based breast reconstruction on both breasts and undergo breast neurotization on the right breast.
ARM II: Patients undergo nipple sparing mastectomy with implant-based breast reconstruction on both breasts and undergo breast neurotization on the left breast.
Patients undergo Semmes-Weinstein monofilament test (SWMT) throughout the study.
Following completion of study intervention, patients are followed up at 1-2 weeks,1, 3, 6, 12 and 24 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationLaura and Isaac Perlmutter Cancer Center at NYU Langone
Principal InvestigatorMihye Choi
