Skip to main content
OpenTrials
Completed

NCT Number: NCT01666899

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with invasive breast cancer who will require mastectomy and postmastectomy radiation therapy.
  • Patients who meet criteria 1, who plan on postmastectomy breast reconstruction

Exclusion criteria

  • Male patients
  • Patients under the age of 18
  • Patients of advanced age (greater than 75)
  • Patients with comorbidities that affect wound healing.

Treatment and study plan

Skin and blood vessel procedures

Procedure

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

Primary outcomes

  1. To evaluate cellular and histologic changes in mastectomy skin over time following completion of radiation therapy.

    Time frame: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction

Secondary outcomes

  1. To evaluate the vascular density of the skin and perfusion changes following radiation therapy.

    Time frame: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction

Other outcomes

  1. To evaluate changes in internal mammary vessel structure and flow characteristics over time following completion of radiation therapy.

    Time frame: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 16, 2012
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.