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