Neurotization for Sensation After Nipple Sparing Mastectomy

This study is looking at whether patients who have a nipple-sparing mastectomy (NSM) are willing to join a larger study comparing NSM with or without a procedure called neurotization. Neurotization is a surgical technique that uses a nerve graft to try and restore sensation to the nipple and areola (the darker skin around the nipple). Many patients who have NSM report less nipple sensation, and this study also wants to see if neurotization can improve quality of life and sexual function. This study is for women aged 18 or older who are planning to have an NSM for certain stages of breast cancer (Anatomic Stage 0, I, or IIA). The main goal is to see how many patients are willing to participate in a randomized study comparing these two approaches. About 20 patients are expected to enroll.

Study design
This is an interventional study that will randomly assign participants to either receive standard nipple-sparing mastectomy (NSM) or NSM with neurotization. It aims to enroll 20 women.
What's involved
Participants will undergo either a standard NSM or an NSM with a nerve graft. They will also complete questionnaires and have follow-up appointments.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 years after their surgery, with appointments at 14 days, and at 6, 12, and 24 months.

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NCT06153836

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~45 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Neurotization ProcedureQuestionnaire AdministrationSubcutaneous Mastectomy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized trial of NSM with or without neurotization
Measured over Up to 2 years
Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
1 sites across 1 states
Florida1
  • James W. Jakub, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic
  • Olivia S. Ho, M.D., M.S. · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

Female patients age \>= 18
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Planned nipple sparing mastectomy (NSM)
Ideal NSM candidates would meet the following criteria:
Cup size A-C
BMI \<34
Ptosis grade \< 2
Clinical stage 0 - T2N0
Final planned implant volume \< 400cc
Inframammary or lateral mammary incision
Tumor \> 0.5cm from the nipple areolar complex (NAC)
No prior breast reduction, mastopexy, or periareolar incisions on side of planned NSM
No prior breast radiation on side of planned NSM
Tumor \<0.5cm from NAC (including suspicious calcifications or MRI enhancement)
No planned post mastectomy radiation (PMRT)
No nicotine use within 4 weeks of surgical date

Exclusion

Planned autologous reconstruction (immediate or delayed)
Pregnancy
  • Percentage of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized trial of NSM with or without neurotizationUp to 2 years

    Will calculate the proportion of eligible patients who opt to take part in the study. Additionally, will descriptively analyze and report the specific factors that influenced patients' decisions to participate, with the aim of identifying and addressing any obstacles encountered.