Clinical trial · Interventional
Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage 0 Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neurotization Procedure | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Subcutaneous Mastectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ARM I (control)
- description
- Patients undergo standard of care NSM on study.
- interventionNames
- Other: Questionnaire Administration
- Procedure: Subcutaneous Mastectomy
- type
- EXPERIMENTAL
- label
- ARM II (neurotization)
- description
- Patients undergo neurotization during standard of care NSM on study.
- interventionNames
- Procedure: Neurotization Procedure
- Other: Questionnaire Administration
- Procedure: Subcutaneous Mastectomy
Primary outcomes (1)
- measure
- Percentage of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized trial of NSM with or without neurotization
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available