Effect of Radiation on Tissue for Delayed Breast Reconstruction
2 other identifiers
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2012
CompletedFirst Posted
Study publicly available on registry
August 16, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2015
CompletedMay 30, 2017
May 1, 2017
2.7 years
August 14, 2012
May 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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 Outcomes (1)
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
Study Arms (1)
Skin and blood vessel procedures
EXPERIMENTALAll 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.
Interventions
Biopsies, skin blood flow studies and ultrasound studies will be performed as described.
Eligibility Criteria
You may qualify if:
- Patients with invasive breast cancer who will require mastectomy and postmastectomy radiation therapy.
- Patients who meet criteria 1, who plan on postmastectomy breast reconstruction
You may not qualify if:
- Male patients
- Patients under the age of 18
- Patients of advanced age (greater than 75)
- Patients with comorbidities that affect wound healing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adeyiza Momoh, MD
Univeristy of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2012
First Posted
August 16, 2012
Study Start
October 1, 2012
Primary Completion
June 15, 2015
Study Completion
June 15, 2015
Last Updated
May 30, 2017
Record last verified: 2017-05