Restoring nipple sensation after breast cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the willingness of patients undergoing nipple sparing mastectomy (NSM) to participate in a randomized study comparing NSM with and without neurotization of the nipple areolar complex (NAC). The study aims to assess patient-reported outcomes, including quality of life and sexual functionality, as well as the restoration of NAC sensation after 12 months. Patients will be randomized into two groups: one receiving standard NSM and the other receiving NSM with neurotization. Follow-up assessments will occur at 14 days, 6, 12, and 24 months post-surgery to monitor outcomes and complications.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic in Florida
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: James W. Jakub, M.D. — Mayo Clinic
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Navigation program to boost survivorship support participation for non-metastatic breast cancer survivors

  This program tests whether a patient navigation service helps non-metastatic breast cancer survivors use survivorship support services more often.

  Recruiting Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT07699991

• Resistant potato starch to reduce joint and muscle symptoms in people starting aromatase inhibitors for early-stage or high-risk breast cancer

  This phase II trial will test whether taking resistant potato starch can reduce joint pain and stiffness in people with stage 0–III or high-risk breast cancer who are starting aromatase inhibitor therapy.

  Recruiting Phase 2 University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT07443943

• 5-strain probiotic to prevent bone loss during aromatase inhibitor therapy

  This trial will try a 5-strain probiotic called WBF-038 to see if it prevents bone loss in people with early-stage hormone receptor–positive breast cancer who are starting aromatase inhibitor therapy.

  Recruiting Phase 2 Mayo Clinic · Jacksonville, Florida · NCT07044310

• Improving skin quality and self-esteem in breast cancer survivors on hormone therapy

  This study is testing how hormone therapy affects skin quality and self-esteem in breast cancer survivors, while also offering skincare advice to see if it helps them feel better about themselves.

  Recruiting Mayo Clinic · Jacksonville, Florida · NCT06401889

• Personalized tumor vaccine with checkpoint inhibitors for triple negative breast cancer

  This phase I trial will test whether a personalized tumor membrane vesicle (TMV) vaccine, given alone or with pembrolizumab or ipilimumab, can boost immune response and help control disease in adults with triple negative breast cancer.

  Recruiting at 4 sites Phase 1 Emory University · Atlanta, Georgia and 3 other locations · NCT06324240

• Using minoxidil to treat hair loss in breast cancer patients on endocrine therapy

  This study is testing if a hair loss treatment called minoxidil, given either as a foam or a pill, can help women with breast cancer who are losing their hair due to cancer therapy.

  Recruiting Early Phase 1 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT05417308

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.