RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-12-05
Study Completion:2025-11-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06153836

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female patients age \>= 18
  2. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  3. * Planned nipple sparing mastectomy (NSM)
  4. * Ideal NSM candidates would meet the following criteria:
  5. * Cup size A-C
  6. * BMI \<34
  7. * Ptosis grade \< 2
  8. * Clinical stage 0 - T2N0
  9. * Final planned implant volume \< 400cc
  10. * Inframammary or lateral mammary incision
  11. * Tumor \> 0.5cm from the nipple areolar complex (NAC)
  12. * No prior breast reduction, mastopexy, or periareolar incisions on side of planned NSM
  13. * No prior breast radiation on side of planned NSM
  14. * Tumor \<0.5cm from NAC (including suspicious calcifications or MRI enhancement)
  15. * No planned post mastectomy radiation (PMRT)
  16. * No nicotine use within 4 weeks of surgical date
  1. * Planned autologous reconstruction (immediate or delayed)
  2. * Pregnancy

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

James W. Jakub, M.D.
PRINCIPAL_INVESTIGATOR
Mayo Clinic
Olivia S. Ho, M.D., M.S.
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • James W. Jakub, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic
  • Olivia S. Ho, M.D., M.S., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-05
Study Completion Date2025-11-10

Study Record Updates

Study Start Date2023-12-05
Study Completion Date2025-11-10

Terms related to this study

Additional Relevant MeSH Terms

  • Anatomic Stage 0 Breast Cancer AJCC v8
  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage IIA Breast Cancer AJCC v8