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

Description

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

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Anatomic Stage 0 Breast Cancer AJCC v8
Intervention / Treatment

-

Contacts and Locations

Jacksonville

Mayo Clinic in Florida, Jacksonville, Florida, United States, 32224-9980

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Planned autologous reconstruction (immediate or delayed)
  • * Pregnancy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mayo Clinic,

James W. Jakub, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Olivia S. Ho, M.D., M.S., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

2025-11-10