Effect of Radiation on Tissue for Delayed Breast Reconstruction

NCT ID: NCT01666899

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-06-15

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Skin and blood vessel procedures

Intervention Type: PROCEDURE

Biopsies, skin blood flow studies and ultrasound studies will be performed as described.

Interventions

Skin and blood vessel procedures

Biopsies, skin blood flow studies and ultrasound studies will be performed as described.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adeyiza Momoh, MD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00059038

Identifier Type: OTHER

Identifier Source: secondary_id

2012.032

Identifier Type: -

Identifier Source: org_study_id