Effect of Radiation on Tissue for Delayed Breast Reconstruction



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:October 2012
End Date:February 2017

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The purpose of this study is to investigate the effects of radiation therapy following
mastectomy on skin and blood vessels and to use information gathered to determine an ideal
time for breast reconstruction after radiation.

In the setting of post-mastectomy radiation therapy delayed autologous reconstruction,
favored by many attempts to avoid complications encountered with radiating the immediately
reconstructed breast. The timing of delayed reconstruction is however not known. The goal of
this proposal is to study the gross, structural and vascular changes in radiated mastectomy
skin in addition to possible structural and flow changes of the underlying internal mammary
vessels over time. We plan to use these objective findings as a basis for determining an
ideal time frame for delayed autologous breast reconstruction.

Sequential mastectomy skin specimens will be obtained from 20 patients undergoing
post-mastectomy radiation therapy over a 24 month period and these specimens will be
evaluated histologically. These same patients will also undergo serial examinations and
photographic documentation of gross skin changes. Skin perfusion will be assessed by laser
Doppler imaging and internal mammary vessel structure, and flow characteristics will be
assessed by color Doppler sonography.

Based on these studies, we will elucidate short and long term changes in radiated breast
skin, showing inflammatory, structural and perfusion patterns that can be correlated with
optimal conditions for reconstruction. This has the potential to dramatically change
practice patterns of delayed reconstruction for many reconstructive surgeons and more
importantly restore what patients loose with mastectomy in a consistent, timely fashion.
There is also potential for improved outcomes of delayed breast reconstruction by decreasing
the number of reconstructions performed too soon after completion of radiation.

Inclusion Criteria:

1. Patients with invasive breast cancer who will require mastectomy and postmastectomy
radiation therapy.

2. Patients who meet criteria 1, who plan on postmastectomy breast reconstruction

Exclusion Criteria:

1. Male patients

2. Patients under the age of 18

3. Patients of advanced age (greater than 75)

4. Patients with comorbidities that affect wound healing.
We found this trial at
1
site
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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mi
from
Ann Arbor, MI
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