Neurotization for Sensation After Nipple Sparing Mastectomy
This study is looking at whether patients who have a nipple-sparing mastectomy (NSM) are willing to join a larger study comparing NSM with or without a procedure called neurotization. Neurotization is a surgical technique that uses a nerve graft to try and restore sensation to the nipple and areola (the darker skin around the nipple). Many patients who have NSM report less nipple sensation, and this study also wants to see if neurotization can improve quality of life and sexual function. This study is for women aged 18 or older who are planning to have an NSM for certain stages of breast cancer (Anatomic Stage 0, I, or IIA). The main goal is to see how many patients are willing to participate in a randomized study comparing these two approaches. About 20 patients are expected to enroll.
- Study design
- This is an interventional study that will randomly assign participants to either receive standard nipple-sparing mastectomy (NSM) or NSM with neurotization. It aims to enroll 20 women.
- What's involved
- Participants will undergo either a standard NSM or an NSM with a nerve graft. They will also complete questionnaires and have follow-up appointments.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 2 years after their surgery, with appointments at 14 days, and at 6, 12, and 24 months.
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Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- James W. Jakub, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic
- Olivia S. Ho, M.D., M.S. · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Percentage of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized trial of NSM with or without neurotizationUp to 2 years
Will calculate the proportion of eligible patients who opt to take part in the study. Additionally, will descriptively analyze and report the specific factors that influenced patients' decisions to participate, with the aim of identifying and addressing any obstacles encountered.