Prospective Assessment of Radiation-induced Heart Injury in Left-sided Breast Cancer

Study Overview
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Brief Summary
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This study is to prospectively investigate the cardiac dose-sparing effect and clinical benefit of deep inspiration breath-hold (DIBH) technique. Patients with left-sided breast cancer treated with breast conserving surgery followed by radiotherapy is enrolled. Radiotherapy is delivered with either free-breathing or deep inspiration breath-hold (DIBH) technique. The cardiac dose parameters and cardiac toxicity are prospective evaluated, and the dose-effect relationship is analyzed.

Detailed Description
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Patients with left-sided breast cancer treated with breast conserving surgery are prospectively enrolled. Two types of radiation treatment are delivered based on attending physician's preferences: radiation to whole breast +- regional nodal areas with free-breathing technique, or with deep inspiration breath-hold (DIBH) technique. The cardiac dose parameters including heart dose and the dose to left anterior coronary artery are assessed, and the cardiac toxicities regularly assessed with cardiac enzymes,electrocardiogram(ECG) and normal gated single-photon emission computed tomography-myocardial perfusion imaging before, during and after radiation.The dose-effect relationship of heart injuries is analyzed.

Official Title
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Prospective Assessment of Radiation-induced Heart Injury in Left-sided Breast Cancer Treated With Breast Conserving Surgery Followed by Radiotherapy With Free-breathing or Deep Inspiration Breath-hold (DIBH) Technique

Conditions
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Breast Neoplasms, Heart Injuries, Radiation Toxicity

Intervention / Treatment
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* Radiation: free-breathing
* Radiation: deep inspiratory breath-holding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Left-sided breast cancer Underwent breast conserving surgery Planned for postoperative whole breast +- regional nodal radiotherapy No basic heart disease Exclusion Criteria: Abnormal cardiac baseline examination History of chest radiation Can not tolerate deep inspiratory breath-holding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Free-breathing<br>standard treatment | Radiation: free-breathing<br>* patients are irradiated to whole breast +- regional nodal areas with free-breathing technique after breast conserving surgery<br>|
| Experimental: Deep inspiratory breath-holding<br>new technique | Radiation: deep inspiratory breath-holding<br>* patients are irradiated to whole breast +- regional nodal areas with deep inspiratory breast-holding technique after breast conserving surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related cardiac adverse events as assessed by CTCAE v4.0 | The cardiac adverse events are regularly assessed with cardiac symptoms,cardiac enzymes(TnT，BNP),electrocardiogram(ECG) and normal gated single-photon emission computed tomography-myocardial perfusion imaging. | up to 2 years |