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Recruiting NCT06153836

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

Phase II Interventional Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neurotization Procedure, Questionnaire Administration, Subcutaneous Mastectomy.
Who it may be relevant to
Registry conditions: Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Procedure Neurotization Procedure
    Undergo placement of nerve graft
  • Other Questionnaire Administration
    Ancillary studies
  • Procedure Subcutaneous Mastectomy
    Undergo standard of care NSM

Primary outcome measures

  • Percentage of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized trial of NSM with or without neurotization [Time frame: Up to 2 years]
Secondary outcome measures (8)
  • Chest physical well-being [Time frame: At baseline and up to 12 months]
  • Psychosocial well-being [Time frame: At baseline and up to 12 months]
  • Sexual well-being [Time frame: At baseline and up to 12 months]
  • Patient reported amount of sensation in nipple areolar complex (NAC) and breast [Time frame: At baseline and up to 12 months]
  • Patient reported significance of breast or NAC for sexuality [Time frame: At baseline and up to 12 months]
  • Tactile sensitivity scores [Time frame: At baseline and up to 12 months]
  • Incidence of adverse events (AEs) [Time frame: At 12 months]
  • Mastectomy skin flap necrosis [Time frame: At 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Florida — Jacksonville

Identifiers

NCT: NCT06153836 · MC230302 · NCI-2023-09574 · 23-004411 · MC230302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗