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Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction

Anatomic Stage I Breast Cancer AJCC v8 Clinical Trial

Official title:
Randomized Feasibility Study to Determine the Feasibility of Neurotization of the Nipple Areolar Complex at the Time of Nipple Sparing Mastectomy and Prosthetic Based Reconstruction

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06153836
Study type Interventional
Source Mayo Clinic
Contact
Status Recruiting
Phase Phase 2
Start date December 5, 2023
Completion date November 10, 2025
View Details
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