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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free-breathing | Active Comparator | standard treatment |
|
| Deep inspiratory breath-holding | Experimental | new technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| free-breathing | Radiation | patients are irradiated to whole breast +- regional nodal areas with free-breathing technique after breast conserving surgery |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
female only
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| Name | Affiliation | Role |
|---|---|---|
| Shulian Wang, M.D. | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | 100021 | China | |||
| Cancer Hosptical, Chinese Academy of Medical Sciences |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D006335 | Heart Injuries |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| deep inspiratory breath-holding | Radiation | patients are irradiated to whole breast +- regional nodal areas with deep inspiratory breast-holding technique after breast conserving surgery |
|
| Beijing |
| 100021 |
| China |
| D017437 |
| Skin and Connective Tissue Diseases |
| D013898 | Thoracic Injuries |
| D014947 | Wounds and Injuries |