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FEASABILITY STUDY TO DETERMINE THE FEASIBILITY OF NEUROTIZATION OF THE NIPPLE AREOLAR COMPLEX AT THE TIME OF NIPPLE SPARING MASTECTOMY AND PROSTHETIC BASED RECONSTRUCTION

Overview

Información sobre este estudio

This is a prospective, phase II trial to assess feasibility of patients undergoing NSM willingness to be randomized to neurotization or not. Feasibility is to be established in preparation for a larger, multi-site randomized prospective trial aimed at determining if neurotization improves objective and subjective patient outcomes. Patients undergoing NSM through an inframammary incision with prosthetic-based reconstruction will be randomized to undergo neurotization of the NAC (intervention) or not (control).

Feasibility will be defined as the accrual of 7 patients within a year (or 14 patients within 2 years).

Hypothesis: Patients undergoing NSM will be willing to enroll in a randomized trial to determine if neurotization improves patient-reported satisfaction outcomes and improves sensation, compared with nipple sparing mastectomy without neurotization.

1. Primary Objective

To determine willingness of patients undergoing NSM to enroll in a randomized trial of NSM with or without neurotization.

2. Secondary Objectives

  1. To compare patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization.
  2. To compare NAC sensation at 12 months in patients undergoing NSM with or without neurotization.
  3. To determine rate of mastectomy skin flap necrosis following NSM via the SKIN score.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

* Female patients age \>= 18 undergoing NSM
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Cup size A-C
* Body mass index (BMI) =\< 34
* Ptosis grade =\< 2
* Clinical stage 0 - T2N0
* Final planned implant volume =\< 400cc
* Inframammary or lateral mammary incision

Exclusion Criteria:

* Prior history of breast cancer on side of planned NSM
* Prior breast reduction, augmentation or mastopexy on side of planned NSM
* Prior periareolar incision \>= 3.1cm on side of planned NSM
* Prior breast radiation (mantle field radiation also excluded) on side of planned NSM
* Planned autologous reconstruction (immediate or delayed)
* Tumor =\< 0.9cm from NAC (including suspicious calcifications or magnetic resonance imaging (MRI) enhancement)
* Clinically node positive
* Planned post mastectomy radiation (PMRT)
* Planned breast splitting incision
* Active nicotine use (within 4 weeks of surgical date)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/13/2024. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Jacksonville, Fla.

Investigador principal de Mayo Clinic

James Jakub, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20556503

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