Effect of Radiation on Tissue for Delayed Breast Reconstruction

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Skin and blood vessel procedures

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Skin and blood vessel procedures; All patients will be placed into Arm 1. They will undergo punch biopsies of the breast skin at the time of mastectomy and at 2, 4, 6, 8 and 12 months after completion of radiation therapy. Three more biopsies will be taken at 3, 6, and 12 months after completion of reconstruction. Patients will also undergo skin blood flow studies with a laser imaging device prior to each biopsy procedure. Ultrasound studies of the chest vessels will be performed 4 times over the course of the study- once prior to radiation and at 2, 6 and 12 months after radiation.

Procedure: Skin and blood vessel procedures; Biopsies, skin blood flow studies and ultrasound studies will be performed as described.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate cellular and histologic changes in mastectomy skin over time following completion of radiation therapy.	2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the vascular density of the skin and perfusion changes following radiation therapy.	2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction

Other Outcome Measures

Outcome Measure	Time Frame
To evaluate changes in internal mammary vessel structure and flow characteristics over time following completion of radiation therapy.	2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: Adeyiza Momoh, MD, Univeristy of Michigan

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): June 15, 2015
• Study Completion (Actual): June 15, 2015

Study Registration Dates

• First Submitted: August 14, 2012
• First Submitted That Met QC Criteria: August 14, 2012
• First Posted (Estimate): August 16, 2012

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 24, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2012.032; HUM00059038 (Other Identifier: University of Michigan Medical School IRB)

Drug and device information, study documents

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