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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-05

Study Completion Date

2026-11-10

Brief Summary

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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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Detailed Description

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PRIMARY OBJECTIVE:

I. To determine willingness of patients undergoing NSM to enroll in a randomized trial of NSM with or without neurotization.

SECONDARY OBJECTIVES:

I. To compare patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization.

II. To compare NAC sensation at 12 months in patients undergoing NSM with or without neurotization.

III To determine rate of mastectomy skin flap necrosis following NSM via the skin ischemia and necrosis (SKIN) score.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo standard of care NSM on study.

ARM II: Patients undergo neurotization during standard of care NSM on study.

After completion of study intervention, patients are followed at 14 days and at 6, 12 and 24 months postoperatively.

Conditions

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Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ARM I (control)

Patients undergo standard of care NSM on study.

Group Type ACTIVE_COMPARATOR

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Subcutaneous Mastectomy

Intervention Type PROCEDURE

Undergo standard of care NSM

ARM II (neurotization)

Patients undergo neurotization during standard of care NSM on study.

Group Type EXPERIMENTAL

Neurotization Procedure

Intervention Type PROCEDURE

Undergo placement of nerve graft

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Subcutaneous Mastectomy

Intervention Type PROCEDURE

Undergo standard of care NSM

Interventions

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Neurotization Procedure

Undergo placement of nerve graft

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Subcutaneous Mastectomy

Undergo standard of care NSM

Intervention Type PROCEDURE

Other Intervention Names

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Nerve Regeneration Procedure Nipple-Sparing Mastectomy

Eligibility Criteria

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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