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Effect of Radiation on Tissue for Delayed Breast Reconstruction

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Michigan Cancer Center
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01666899
First received: August 14, 2012
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Procedure: Skin and blood vessel procedures

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of Radiation on Tissue for Delayed Breast Reconstruction

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • 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 radition therapy; 3, 6, 12 months post reconstruction ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666899

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cancer Answer Line    800-865-1125    canceranswerline@umich.edu   
Contact: Anna Shafto    734-232-0758    ashafto@umich.edu   
Principal Investigator: Adeyiza Momoh, MD         
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Adeyiza Momoh, MD Univeristy of Michigan
  More Information

No publications provided

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01666899     History of Changes
Other Study ID Numbers: 2012.032, HUM00059038
Study First Received: August 14, 2012
Last Updated: June 26, 2013
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 27, 2014