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

Launched by MAYO CLINIC · Nov 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical technique aimed at helping women with breast cancer who are undergoing a procedure called nipple-sparing mastectomy (NSM). This surgery is often chosen to remove breast tissue while keeping the nipple and areola intact. However, many women experience loss of sensation in the nipple area after the surgery. The trial is exploring whether a procedure called neurotization, which uses a nerve graft to restore feeling, can improve sensation and overall quality of life for these patients. Participants will be randomly assigned to either have the neurotization or just undergo the standard NSM, and their experiences will be compared, including how they feel about their breast and nipple area after surgery.

To join the trial, women must be at least 18 years old and have a specific type of breast cancer at an early stage. Ideal candidates should have a breast cup size of A to C, a certain body mass index, and meet other health criteria. Participants can expect to receive personalized care, and their feedback will help researchers understand how the procedure affects feelings of sensation and quality of life after surgery. It’s important to know that women who are pregnant or planning certain types of breast reconstruction may not be eligible for this study.

Gender

FEMALE

Eligibility criteria

• 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 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
• Exclusion Criteria:
• • Planned autologous reconstruction (immediate or delayed)
• • Pregnancy