Large Segmentation Radiotherapy±Deep Inspiratory Breath Hold for Left Sided Breast Cancer, A Real-World Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- Incidence of subclinical and clinical cardiac events
研究概览
简要总结
The study is a single-center, prospective, non-randomized controlled study. The primary objective is to examine the clinical outcomes of utilizing Deep Inspiration Breath Hold (DIBH) in conjunction with hypo-fractionated radiotherapy for patients diagnosed with left-sided breast cancer with a particular focus on its potential to reduce the incidence of cardiac-related clinical and subclinical events.Participants will revieve large segmentation sadiotherapy ± DIBH for left breast cancer and be followed up to gather their clinical cardiac imformation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18-70 years old, female, life expectancy > 5 years
- •ECOG 0, 1, 2 points
- •Pathologically diagnosed with left breast cancer and underwent breast-conserving surgery or modified radical mastectomy
- •The patient will receive radiation therapy to the entire breast or chest wall ± the lymphatic drainage area above and below the clavicle ± the lymphatic drainage area in the axilla.
- •No prior neoadjuvant chemotherapy or breast reconstruction.
- •No active cardiac disease, myocardial infarction, or congestive cardiac failure at baseline.
- •Patients can hold their breath for at least 30 seconds after training
- •Patients who can be followed up and agree to follow the plan.
- •Sign the consent form.
排除标准
- •Lesions were observed on both sides of the breast.
- •Diagnosis could not be confirmed by pathology.
- •Distant metastasis was identified.
- •The patient had undergone neoadjuvant chemotherapy or breast reconstruction surgery.
- •Severe cardiac insufficiency; myocardial infarction or uncorrected unstable cardiac arrhythmia or uncorrected unstable angina within the last 3 months; or pericardial disorders
- •The patient's New York Heart Association (NYHA) cardiac classification is within categories 2-
- •A history of chronic lung disease, including conditions that may contribute to ductal dilatation, such as chronic obstructive pulmonary disease (COPD) and interstitial pneumonia.
- •Previous mediastinal radiotherapy.
- •Previous or concurrent second primary malignant tumor (except skin cancer that is not a malignant black pigmented tumor, papillary/follicular carcinoma of the thyroid, carcinoma in situ of the cervix, and contralateral non-invasive breast cancer).
- •Irradiation of the lymphatic drainage area of the internal breast is required.
结局指标
主要结局
Incidence of subclinical and clinical cardiac events
时间窗: through study completion, an average of 1 year
1. Clinical events: newly emerged cardiac diseases after radiotherapy include acute and delayed pericarditis, pericardial effusion and constrictive pericarditis, coronary artery disease, myocardial infarction, cardiac valve disease and arrhythmia. 2. Subclinical events: new electrocardiogram (ECG) abnormalities, echocardiographic abnormalities, and abnormal elevations of cardiac enzymes after radiotherapy.
次要结局
- Survival(through study completion, an average of 1 year)
- Cosmetic results(through study completion, an average of 1 year)
- Life quality(through study completion, an average of 1 year)