Clinical trial NCT01666899: Effect of Radiation on Tissue for Delayed Breast Reconstruction
Official title: Effect of Radiation on Tissue for Delayed Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate cellular and histologic changes in mastectomy skin over time following completion of radiation therapy.
timeFrame: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
Secondary outcomes:
measure: To evaluate the vascular density of the skin and perfusion changes following radiation therapy.
timeFrame: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
Other outcomes:
measure: To evaluate changes in internal mammary vessel structure and flow characteristics over time following completion of radiation therapy.
timeFrame: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Univeristy of Michigan
name: Adeyiza Momoh, MD
role: PRINCIPAL_INVESTIGATOR
References: