Effect of Radiation on Tissue for Delayed Breast Reconstruction

Breast Cancer Clinical Trial

Official title:

Effect of Radiation on Tissue for Delayed Breast Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666899
• Other study ID #: 2012.032
• Secondary ID: HUM00059038
• Status: Completed
• Phase: N/A
• First received: August 14, 2012
• Last updated: May 24, 2017
• Start date: October 2012
• Est. completion date: June 15, 2015

Study information

• Verified date: May 2017
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 15, 2015
• Est. primary completion date: June 15, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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