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

RecruitingPhase 2Ages 18 Years - anyFemaleMayo Clinic
NCT06153836 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Neurotization Procedure
  • Questionnaire Administration
  • Subcutaneous Mastectomy
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Where

1 site
Mayo Clinic in Florida
Jacksonville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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