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NCT Number: NCT06153836

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

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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Key information

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

James W. Jakub, M.D.

PRINCIPAL_INVESTIGATOR

Olivia S. Ho, M.D., M.S.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurotization Procedure

Procedure

Undergo placement of nerve graft

Other names: Nerve Regeneration Procedure

Questionnaire Administration

Other

Ancillary studies

Subcutaneous Mastectomy

Procedure

Undergo standard of care NSM

Other names: Nipple-Sparing Mastectomy

Primary outcomes

  1. 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

    Will calculate the proportion of eligible patients who opt to take part in the study. Additionally, will descriptively analyze and report the specific factors that influenced patients' decisions to participate, with the aim of identifying and addressing any obstacles encountered.

Secondary outcomes

  1. Chest physical well-being

    Time frame: At baseline and up to 12 months

    Measured using the BREAST-Q© scored on a 3-point Likert scale where 1=None of the time and 3=All of the time. Higher scores indicate poorer chest physical well-being.

  2. Psychosocial well-being

    Time frame: At baseline and up to 12 months

    Measured using the BREAST-Q© scored on a 5-point Likert scale where 1=None of the time and 5=All of the time. Higher scores indicate poorer psychosocial well-being.

  3. Sexual well-being

    Time frame: At baseline and up to 12 months

    Measured using the BREAST-Q© scored on a 5-point Likert scale where 1=None of the time and 5=All of the time. Higher scores indicate poorer sexual well-being.

  4. Patient reported amount of sensation in nipple areolar complex (NAC) and breast

    Time frame: At baseline and up to 12 months

    Patient reported amount of sensation in nipple areolar complex (NAC) and breast will be will be assessed using a 5-item sensation questionnaire with 5 options to answer each question. Examples of answers include a range from Very unpleasant to Very pleasant or Unimportant to Very Important. Results will be reported descriptively.

  5. Patient reported significance of breast or NAC for sexuality

    Time frame: At baseline and up to 12 months

    Patient reported significance of breast or NAC for sexuality will be assessed using a 5-item Significance of Breast or Nipple Areolar Complex for Sexuality Questionnaire with 5 options to answer each question: Not at all, A little bit, Somewhat, Quite a bit, or Very much. Results will be reported descriptively.

  6. Tactile sensitivity scores

    Time frame: At baseline and up to 12 months

    Measured using Semmes Weinstein monofilament test. Scores will be averaged for each patient across all breast/ NAC measurements and summarized in terms of mean, standard deviation, median, and range. The ordinal score at each of the sites will also be summarized in terms of median and range. Frequency and type of missing data will be summarized.

  7. Incidence of adverse events (AEs)

    Time frame: At 12 months

    AEs will be scored using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) and will be summarized within arms by reporting the number and percentage of patients for each AE. The maximum grade for each type of AEs will be recorded for each patient and frequency tables will be reviewed to determine overall patterns. The frequency and type of solicited AEs experienced in each arm will also be reported.

  8. Mastectomy skin flap necrosis

    Time frame: At 12 months

    Incidence of mastectomy skin flap necrosis will be assessed using the skin ischemia necrosis (SKIN) score, as recorded by clinical staff. Necrosis is defined as any depth SKIN score of C or D and surface area >1.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 1, 2023
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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