Clinical trial NCT06153836: Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Anatomic Stage 0 Breast Cancer AJCC v8
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Percentage of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized trial of NSM with or without neurotization
timeFrame: Up to 2 years
Secondary outcomes:
measure: Chest physical well-being
timeFrame: At baseline and up to 12 months
measure: Psychosocial well-being
timeFrame: At baseline and up to 12 months
measure: Sexual well-being
timeFrame: At baseline and up to 12 months
measure: Patient reported amount of sensation in nipple areolar complex (NAC) and breast
timeFrame: At baseline and up to 12 months
measure: Patient reported significance of breast or NAC for sexuality
timeFrame: At baseline and up to 12 months
measure: Tactile sensitivity scores
timeFrame: At baseline and up to 12 months
measure: Incidence of adverse events (AEs)
timeFrame: At 12 months
measure: Mastectomy skin flap necrosis
timeFrame: At 12 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: James W. Jakub, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Olivia S. Ho, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References: