Cardiotoxicity in Breast Cancer Patients Treated With Proton or Photon Radiotherapy: A RadComp Companion Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 6
- 主要终点
- Circulating Growth Differentiation Factor-15 (GDF-15)
研究概览
简要总结
This is a companion study to the "Pragmatic Randomized Trial of Proton vs Photon Therapy for Patients with non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RadComp) Consortium Trial" (NCT02603341). The investigators will collect cardiovascular (CV) biomarkers and echocardiograms prior to, during, and for up to 1 year following radiation for a subset of patients enrolled on RadComp and to evaluate the impact of proton vs photon radiation therapy (RT) on CV function and structure.
详细描述
The study population of the companion study will consist of newly enrolled RadComp trial participants. Patients on this ancillary will be consented prior to RadComp randomization to decrease the bias secondary to RT type and enhance internal validity. The study will define the early changes in biomarkers, imaging measures, and RT dose volume metrics and long-term (5-10 year) CV clinical outcomes using the RadComp parent study's infrastructure for clinical data collection and long-term follow-up. Blood samples, echocardiograms, and questionnaires are obtained at baseline (between end of chemotherapy and start of RT), immediately after the end of RT, and at 6 months and 12 months after the end of RT. An additional blood sample will be collected at 4 weeks after the start of RT. Clinical, demographic, and patient reported outcomes data are collected as part of the RadComp parent study. In addition to data collected by RadComp, we will collect a limited set of clinical data and two additional quality of life instruments for the companion study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consented to RadComp
- •Willing and able to provide written consent
排除标准
- •Knowledge of randomization on RadComp prior to enrollment on companion study
- •Non-diagnostic echocardiography windows as assessed on local read.
研究组 & 干预措施
Ancillary Cohort
No Intervention: Subjects will be followed before, during and for up to 1 year after radiation with echocardiogram, blood draw, and symptoms and activity survey.
干预措施: Proton vs Photon Radiation (Radiation)
结局指标
主要结局
Circulating Growth Differentiation Factor-15 (GDF-15)
时间窗: 14 months
Change in GDF-15 levels from baseline
Left ventricular ejection fraction (LVEF)
时间窗: 14 months
Change in echocardiography derived LVEF from baseline
Right Ventricular (RV) Fractional Area Change (FAC)
时间窗: 14 months
Change in echocardiography derived RV FAC from baseline
Circulating N-terminal pro B-type natriuretic peptide (NTproBNP)
时间窗: 14 months
Change in NTproBNP levels from baseline
Circulating Placental Growth Factor (PIGF)
时间窗: 14 months
Change in PIGF levels from baseline
次要结局
- Diastolic function (E/e')(14 months)
- Echocardiography derived Ventricular Arterial Coupling Measurement(14 months)
- LV systolic strain(14 months)
- Circulating Troponin T(TnT)(14 months)
- Circulating high-sensitivity C-Reactive Protein (hsCRP)(14 months)