RightFit
RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for women with breast cancer planning breast removal that keeps the nipple, followed by breast reconstruction. It tests willingness to join a study that assigns patients by chance to surgery with or without a nerve graft to help restore feeling in the nipple and the darker skin around it. It also compares quality of life and sexual function of the breast and nipple area.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older.
  • Able to do all or most self-care and out of bed for more than half the day (ECOG score 0–2).
  • Planning breast removal surgery that keeps the nipple.
  • Ideal candidates have an A–C cup size, a body mass index (BMI) below 34, and breast sagging below grade 2.
  • Ideal candidates have cancer stage 0–T2N0, a planned implant under 400 cc, and a planned cut under or at the side of the breast.
  • The ideal-candidate list gives conflicting tumor distances: both more than and less than 0.5 cm from the nipple area. Ask the study team which rule applies.
  • Ideal candidates have had no breast reduction, breast lift, cuts around the nipple area, or radiation on the side of the planned surgery.
  • Ideal candidates have no planned radiation after breast removal and no nicotine use within 4 weeks of surgery.

Who can't join

  • Planning breast reconstruction using your own body tissue, either right away or later.
  • Pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

FL