Status:
COMPLETED
Assessment of Ability of Breath Hold for Left-sided Breast Cancer Radiation Therapy to Reduce Side Effects to Heart
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-99 years
Brief Summary
The purpose of this research study is to demonstrate that Deep Inspiration Breath Hold (DIBH), the technique used at the University of North Carolina (UNC) for left-side breast cancer radiation therap...
Detailed Description
The primary objective of this study is to estimate the rate of radiation-associated regional myocardial perfusion defects in patients 6 months after breast/chestwall radiation with DIBH for left-sided...
Eligibility Criteria
Inclusion
- signed an Institutional Review Board (IRB)-approved informed consent document for protocol
- age \>= 18 years
- histologically confirmed left-sided breast cancer scheduled to undergo curative intent radiation treatment post lumpectomy or mastectomy
- stage 0-III left-sided breast cancer (including DCIS)
- SPECT score of 0 at baseline
- radiation oncologist agrees target volume coverage will not be compromised via use of the DIBH technique along with conformal field shaping
Exclusion
- active cardiac disease, defined as a history of angina, arrhythmias, myocardial infarction, congestive heart failure, or any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
- symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
- concurrent chemotherapy
- prior receipt of mediastinal radiation therapy
- pregnant or lactating women
- inability to understand and follow breathing instructions for the DIBH procedure
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01849614
Start Date
March 1 2013
End Date
March 1 2016
Last Update
May 12 2016
Active Locations (1)
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1
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, United States, 27599