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.
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.
Eligibility
Inclusion Criteria:
- Female patients age >= 18 undergoing NSM
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Cup size A-C
- Body mass index (BMI) =< 34
- Ptosis grade =< 2
- Clinical stage 0 - T2N0
- Final planned implant volume =< 400cc
- Inframammary or lateral mammary incision
Exclusion Criteria:
- Prior history of breast cancer on side of planned NSM
- Prior breast reduction or mastopexy on side of planned NSM
- Prior periareolar incision >= 3.1cm or >90 degrees on side of planned NSM
- Prior breast radiation (mantle field radiation also excluded) on side of planned NSM
- Planned autologous reconstruction (immediate or delayed)
- Tumor =< 0.5cm from NAC (including suspicious calcifications or magnetic resonance imaging (MRI) enhancement)
- Planned post mastectomy radiation (PMRT)
- Planned breast splitting incision
- Active nicotine use (within 4 weeks of surgical date)
- Pregnancy