Restoring nipple sensation after breast cancer surgery
Randomized Feasibility Study to Determine the Feasibility of Neurotization of the Nipple Areolar Complex at the Time of Nipple Sparing Mastectomy and Prosthetic Based Reconstruction
This study is testing if adding a special technique to nipple-sparing surgery can help women with breast cancer regain feeling in their nipples and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06153836 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the willingness of patients undergoing nipple sparing mastectomy (NSM) to participate in a randomized study comparing NSM with and without neurotization of the nipple areolar complex (NAC). The study aims to assess patient-reported outcomes, including quality of life and sexual functionality, as well as the restoration of NAC sensation after 12 months. Patients will be randomized into two groups: one receiving standard NSM and the other receiving NSM with neurotization. Follow-up assessments will occur at 14 days, 6, 12, and 24 months post-surgery to monitor outcomes and complications.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older, with specific criteria related to breast size, BMI, and tumor characteristics, who are planning to undergo nipple sparing mastectomy.
Not a fit: Patients who have planned autologous reconstruction or are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve nipple sensation and quality of life for breast cancer patients undergoing mastectomy.
How similar studies have performed: While the concept of neurotization is not widely tested in this context, similar approaches in nerve grafting have shown promise in restoring sensation in other surgical settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: James W. Jakub, M.D. — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.