Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06153836

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

Led by Mayo Clinic · Updated on 2025-12-04

20

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients age  18
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Planned nipple sparing mastectomy (NSM)
  • Cup size A-C
  • Body mass index (BMI) less than 34
  • Ptosis grade less than 2
  • Clinical stage 0 to T2N0 breast cancer
  • Final planned implant volume less than 400 cc
  • Planned inframammary or lateral mammary incision
  • Tumor more than 0.5 cm from the nipple areolar complex (NAC)
  • No prior breast reduction, mastopexy, or periareolar incisions on the side of planned NSM
  • No prior breast radiation on the side of planned NSM
  • No planned post-mastectomy radiation therapy (PMRT)
  • No nicotine use within 4 weeks of surgery
Not Eligible

You will not qualify if you...

  • Planned autologous reconstruction (immediate or delayed)
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224-9980

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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