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

Last updated: February 21, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

2

Condition

Breast Cancer

Ductal Carcinoma In Situ (Dcis)

Treatment

Questionnaire Administration

Subcutaneous Mastectomy

Neurotization Procedure

Clinical Study ID

NCT06153836
MC230302
23-004411
NCI-2023-09574
MC230302
  • Ages > 18
  • Female

Study 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 Criteria

Inclusion

Inclusion 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 ofplanned 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

Exclusion Criteria:

  • Planned autologous reconstruction (immediate or delayed)

  • Pregnancy

Study Design

Total Participants: 14
Treatment Group(s): 3
Primary Treatment: Questionnaire Administration
Phase: 2
Study Start date:
December 05, 2023
Estimated Completion Date:
November 10, 2025

Study Description

PRIMARY OBJECTIVE:

I. To determine willingness of patients undergoing NSM to enroll in a randomized trial of NSM with or without neurotization.

SECONDARY OBJECTIVES:

I. To compare patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization.

II. To compare NAC sensation at 12 months in patients undergoing NSM with or without neurotization.

III To determine rate of mastectomy skin flap necrosis following NSM via the skin ischemia and necrosis (SKIN) score.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo standard of care NSM on study.

ARM II: Patients undergo neurotization during standard of care NSM on study.

After completion of study intervention, patients are followed at 14 days and at 6, 12 and 24 months postoperatively.

Connect with a study center

  • Mayo Clinic in Florida

    Jacksonville, Florida 32224-9980
    United States

    Active - Recruiting

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