Clinical trial NCT03135392: Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mastectomy
Breast Reconstruction
Keywords: Breast Cancer
sensation recovery
Neurotization
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective cohort study
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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"

Primary outcomes:
measure: Composite measure of sensation
timeFrame: Up to 24 months after surgery
Secondary outcomes:
measure: Quality of Life as measured by a 19-question survey regarding sensation and appearance of breast.
timeFrame: Up to 24 months after surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Andrea Moreira, MD
role: PRINCIPAL_INVESTIGATOR
References: