Assessment of Ability of Breath Hold for Left-sided Breast Cancer Radiation Therapy to Reduce Side Effects to Heart

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Cardiac SPECT perfusion scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient group<br>Women with left-sided breast cancer | Other: Cardiac SPECT perfusion scan<br>* A SPECT cardiac perfusion scan provides a three-dimensional map of blood flow to the heart tissue. The scan will be taken at rest only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cardiac perfusion | 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. | 6-months post radiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wall-motion abnormalities | The incidence of wall-motion abnormalities will be assessed using SPECT in the same 12 segment scoring system used to quantify perfusion. Wall-motion abnormalities will be recorded as present or absent in each cardiac segment. When present, wall-motion abnormalities wil be classified as gypokinetic, akinetic, or dyskinetic. The extent of wall involvement (small or large portion) will be described as mild or severe. | 6-months post-treatment |