Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer

Return of Breast Sensation Following Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer: An Evaluation of Clinical, Sensory, and Quality of Life Outcomes

Tissue Expander/Implant Reconstruction: The purpose of this study is to determine how and when nerve sensation to the breast skin returns after mastectomy.

Autologous Tissue Reconstruction: The purpose of this study is to determine whether the tissue being used to reconstruct your breast can provide sensation by using your own nerves. Typically all sensation is lost immediately after this type of surgery and returns to varying degrees. We are hoping to demonstrate that by connecting the two nerves (one from abdomen and one from the chest wall) together, we can attain meaningful sensation in the transferred tissues thereby improving your quality of life following surgery.

Study Overview

• Status: Withdrawn
• Conditions: Breast Reconstruction; Mastectomy
• Intervention / Treatment: Procedure: Breast Reconstruction with Artificial Implant; Procedure: Autologous Breast Reconstruction; Procedure: Neurotization

Detailed Description

To determine the timing and distribution of sensation recovery of breast after mastectomy and breast reconstruction, both with autologous and implant-based reconstruction. Also, to determine the role of innervated free tissue transfer in breast reconstruction.

Specific Aims

1. Determine the timing and degree of return of breast in women who underwent mastectomy with autologous tissue or with implant based reconstruction.
2. Determine sensation following neurotized free flap reconstruction
3. Determine whether neurotization has an impact on quality of life measures post operatively

Study Design Patients will be enrolled prospectively in this data collection study in which they will receive the standard of care for breast cancer resection and oncologically safe and accepted means of breast reconstruction with tissue expander and/or prosthetic implants. Patients will receive additional, non-invasive sensory testing, performed at standard follow up intervals in clinic by their reconstructive team. All patients participating in the study will be consented for enrollment at the pre-operative visit by either the surgeon or physician assistant. As this is a prospective study, all women fitting inclusion criteria over a 6-month minimal, but projected goal 12-month period will be included.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients undergoing unilateral or bilateral skin sparing mastectomy for breast cancer

• Patient must have one of the following reconstructions in planned:

  • Immediate tissue expander placement
  • Immediate implant placement
  • Immediate autologous breast reconstruction
• All patients participating in the study must be willing to be consented for enrollment at the pre-operative visit.

Exclusion Criteria:

• Pre-operative radiation therapy
• Any pre-excising
• Patients with absent or prior damaged nipple areola-complex (NAC) on the "non-surgical breast"

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Breast Reconstruction with Artificial Implant; Participants undergoing unilateral reconstruction: patient will serve as internal control with contralateral breast and reconstructed breast will be compared to all other reconstructed breasts. Participants undergoing bilateral reconstruction: reconstructed breasts will be compared to all other reconstructed breasts	Procedure: Breast Reconstruction with Artificial Implant; Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with artificial implants
Active Comparator: Autologous Breast Reconstruction without Neurotization; Participants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which do not have their nerves reconstructed during surgery	Procedure: Autologous Breast Reconstruction; Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with the patient's own tissue
Experimental: Autologous Breast Reconstruction with Neurotization; Participants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which have a nerve connected (neurotized) during surgery.	Procedure: Autologous Breast Reconstruction; Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with the patient's own tissue; Procedure: Neurotization; Nerve will be reconstructed during autologous breast tissue reconstruction; Other Names: Nerve Reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite measure of sensation	Differences of at least 20% comparing control to experimental breasts would be clinically meaningful. Composite measure will be calculated by combining the follow binomial factors: detection of temperature difference (feeling hot and cold), detection of sharp versus dull pressure, detection of vibration, discerning point pressure	Up to 24 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life as measured by a 19-question survey regarding sensation and appearance of breast.	A total of 19 Likert scale questions will be given to participants in the pre- and post-Surgical Sensation Questionnaire regarding sensation and appearance of breast before and after reconstruction.	Up to 24 months after surgery

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Andrea Moreira, MD, Cleveland Clinic, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Breast Cancer; Neurotization; sensation recovery
• Other Study ID Numbers: CASE2117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No