RecruitingPhase 2NCT06153836

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

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

Sponsor

Mayo Clinic

Enrollment

20 participants

Start Date

Dec 5, 2023

Study Type

INTERVENTIONAL

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a surgical technique called nipple neurotization — where nerves are reconnected to the nipple area during mastectomy reconstruction — to help restore sensation to the nipple and surrounding skin after nipple-sparing mastectomy in women with breast cancer. Loss of sensation is a common and distressing side effect of mastectomy and reconstruction. **You may be eligible if...** - You are a woman aged 18 or older - You are planning to have a nipple-sparing mastectomy (NSM) - You are in reasonable health (ECOG 0, 1, or 2) - You ideally have a cup size A–C, BMI under 34, and a tumor more than 0.5 cm away from the nipple - You have not had prior breast radiation or breast reduction/lift surgery on the side being treated **You may NOT be eligible if...** - You are planning autologous (flap-based) breast reconstruction using your own tissue - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURENeurotization Procedure

Undergo placement of nerve graft

OTHERQuestionnaire Administration

Ancillary studies

PROCEDURESubcutaneous Mastectomy

Undergo standard of care NSM

Locations(1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

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NCT06153836

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