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NCT06153836 | RECRUITING | Anatomic Stage 0 Breast Cancer AJCC V8

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

Mayo Clinic

Brief Summary:

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.

Condition or disease

Anatomic Stage 0 Breast Cancer AJCC V8

Anatomic Stage I Breast Cancer AJCC V8

Anatomic Stage Iia Breast Cancer Ajc V8

Intervention/treatment

Neurotization Procedure

Questionnaire Administration

Subcutaneous Mastectomy

Phase

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 14 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-12-05
Estimated Primary Completion Date : 2025-11-10
Estimated Study Completion Date : 2025-11-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients with Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction

Location Details

NCT06153836

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Locations

RECRUITING

United States, Florida

Mayo Clinic in Florida

Jacksonville, Florida, United States, 32224-9980