Prospective Pilot Study of Assessment of Breath Hold as a Means to Mitigate the Risk of Radiation-associated Reductions in Regional Cardiac Perfusion in Patients With Left-sided Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Changes in cardiac perfusion
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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 therapy, can reduce side effects to the heart.
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 breast cancer. Cardiac perfusion will be assessed using SPECT cardiac perfusion scans pre- and 6 months post-radiation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Changes in cardiac perfusion
Time Frame: 6-months post radiation
Cardiac perfusion will be assessed using SPECT cardiac perfusion scans pre- and 6 months post-radiation. Any post-radiation summed-rest score (SRS) \> 0 will be counted as a perfusion defect in the calculation of the perfusion defect rate.
Secondary Outcomes
- Wall-motion abnormalities(6-months post-treatment)