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

Not Applicable

Withdrawn

• Conditions: Mastectomy; Breast Reconstruction
• Interventions: Procedure: Autologous Breast Reconstruction; Procedure: Breast Reconstruction with Artificial Implant; Procedure: Neurotization

• Registration Number: NCT03135392
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-05-01
• Study Start: 2018-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-12
• Last Update Posted: 2018-11-14
• Primary Completion: 2020-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous Breast Reconstruction without Neurotization	Autologous Breast Reconstruction	Participants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which do not have their nerves reconstructed during surgery
Autologous Breast Reconstruction with Neurotization	Autologous Breast Reconstruction	Participants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which have a nerve connected (neurotized) during surgery.
Autologous Breast Reconstruction with Neurotization	Neurotization	Participants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which have a nerve connected (neurotized) during surgery.
Breast Reconstruction with Artificial Implant	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

Primary Outcome Measures

Name	Time	Method
Composite measure of sensation	Up to 24 months after surgery	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

Secondary Outcome Measures

Name	Time	Method
Quality of Life as measured by a 19-question survey regarding sensation and appearance of breast.	Up to 24 months after surgery	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.

Trial Locations

Locations (1)

Cleveland Clinic, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States