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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Neoplasms
- Sponsor
- Shu lian Wang
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- Number of participants with treatment-related cardiac adverse events as assessed by CTCAE v4.0
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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
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.
Investigators
Shu lian Wang
professor of medicine
Chinese Academy of Medical Sciences
Eligibility Criteria
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
Outcomes
Primary Outcomes
Number of participants with treatment-related cardiac adverse events as assessed by CTCAE v4.0
Time Frame: up to 2 years
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.