Nerve Grafting for Sensation Restoration After Mastectomy in Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial studies if patients are willing to join a study comparing standard nipple sparing mastectomy (NSM) with and without a technique aimed at restoring sensation in the nipple area. The goal is to see if this improves quality of life and sensation for patients.
Do I need to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
Is nerve grafting for sensation restoration after mastectomy generally safe?
Nerve grafting during nipple-sparing mastectomy (NSM) and breast reconstruction is generally safe, with studies showing a high rate of preserved sensation and no reports of severe complications like dysesthesias (abnormal sensations) or neuromas (nerve tissue growths). However, common complications of NSM include risks of necrosis (tissue death) and reduced sensation in the nipple-areola complex.12345
How is the nerve grafting treatment for sensation restoration after mastectomy different from other treatments?
This treatment is unique because it involves preserving and reconnecting nerves during mastectomy to restore sensation in the breast, specifically targeting the nipple-areolar complex. Unlike traditional methods that often leave the area numb, this approach uses nerve grafts to improve sensory outcomes, making it a novel option for patients seeking to regain feeling after breast reconstruction.36789
What data supports the effectiveness of the treatment for sensation restoration after mastectomy?
Research shows that nerve grafting and preservation during nipple-sparing mastectomy can effectively restore sensation, with 90% of patients experiencing preserved or improved sensation in the nipple-areolar complex. This suggests that the treatment is safe and can lead to significant sensory recovery.356910
Who Is on the Research Team?
James W Jakub
Principal Investigator
Mayo Clinic
Olivia Ho, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for female breast cancer patients aged 18 or older who are undergoing nipple sparing mastectomy (NSM) with specific criteria: ECOG status of 0-2, A-C cup size, BMI ≤34, ptosis grade ≤2, clinical stage 0-T2N0, and implant volume ≤400cc. Exclusions include prior breast cancer treatments or surgeries on the affected side and active nicotine use.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients undergo nipple sparing mastectomy (NSM) with or without neurotization
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Neurotization Procedure
- Subcutaneous Mastectomy
Neurotization Procedure is already approved in United States, European Union for the following indications:
- Restoration of nipple sensation after nipple-sparing mastectomy and reconstruction
- Restoration of nipple sensation after nipple-sparing mastectomy and reconstruction
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor