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RECRUITING
NCT06153836
PHASE2

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-12-05

Completion Date

2026-11-10

Last Updated

2025-12-04

Healthy Volunteers

No

Interventions

PROCEDURE

Neurotization Procedure

Undergo placement of nerve graft

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

Subcutaneous Mastectomy

Undergo standard of care NSM

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States