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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMayo Clinic

About this trial

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

Qualifiers

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

Disqualifiers

Planned autologous reconstruction (immediate or delayed)

Pregnancy

Trial design

Treatments tested in this trial

  • Neurotization Procedure
  • Questionnaire Administration
  • Subcutaneous Mastectomy

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators