Protection of Cardiovascular Function With Crocin in BrEast Cancer Patients Undergoing Radiotherapy and Chemotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The change of LVEF measured by echocardiography
研究概览
简要总结
The potential cardiovascular toxicity of tumor treatment and its resulting cardiovascular events have gradually become an important health risk for tumor survivors. Prevention and early identification of cardiovascular toxicity has now become one of the bottlenecks in improving the prognosis of cancer patients. Compared to conventional echocardiographic indicators, new ultrasound technology based on speckle tracking imaging (STI) has shown superiority in the diagnosis, risk stratification and prognosis evaluation of cardiovascular diseases. Crocin, one of the main active components of saffron, has been found protective effect on cardiovascular toxicity in basic studies. This is a randomized, double-blind, placebo-controlled, single-center clinical study to observe the effect of crocin on cardiovascular function caused by breast cancer treatment.
One hundred and twenty breast cancer patients planning to undergo radiotherapy or chemotherapy will be included and randomly divided into a crocin group and a placebo group to observe the effect of total saffron tablets on cardiovascular function in patients with early breast cancer radiotherapy and chemotherapy. Participants will take crocin or placebo (4 tablets/time, 3 times a day) during each cycle of chemotherapy for 8 days, started on the 1st day before radiotherapy/chemotherapy. Follow-up was performed every 3 months after enrollment, and the follow-up period was 6 months.
Primary study endpoints include the differences between groups in the difference in LVEF and GLS measured by echocardiography at the end of the experiment compared to baseline. Secondary study endpoint include the differences in the incidence rates of serum troponin exceeding the upper limit of normal value and NT-proBNP higher than the normal age reference value, the frequency and duration of chest tightness, chest pain and palpitation, the degree of arrhythmia and ST-T changes displayed by dynamic electrocardiogram, the other echocardiographic parameters (the E/e', global circumferential strain, global radial strain, 3D-GAS, LV torsion, LV rotation/derotation velocity, SDI, RVFWS, and indexes of left ventricular diastolic function and right ventricular function) at the end of the experiment compared to baseline between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Crocin group
The chemotherapy/radiotherapy protocols are made by oncologists adopted for patients depending on specific conditions , take saffron total glucosides tablets(provided by Reyoung Pharmaceutical Co., Ltd.) for 8 days during each chemotherapy (started on the 1st day before chemotherapy), 4 tablets/time, 3 times a day.
干预措施: crocin (Drug)
placebo group
Undergoing chemotherapy/radiotherapy protocols as planned, take placebo piece during(the same appearance of crocin tablets, production unit:Reyoung Pharmaceutical Co., Ltd.) for 8 days during each chemotherapy (started on the 1st day before chemotherapy), 4 tablets/time, 3 times a day
干预措施: Placebo (Drug)
结局指标
主要结局
The change of LVEF measured by echocardiography
时间窗: At the end of 6-month follow-up compared to the baseline
The differences between the two groups in the difference of LVEF measured by Echocardiography at the end of the experiment compared to that at the baseline.
The change of GLS measured by echocardiography
时间窗: At the end of 6-month follow-up compared to the baseline
The differences between the two groups in the difference of GLS measured by Echocardiography at the end of the experiment compared to that at the baseline.
次要结局
- The indexe of right ventricular free wall global longitudinal strain (RVGLS) measured by echocardiography.(At the end of 6-month follow-up compared to the baseline)
- The incidences of the increase of serum troponin and/or NT-proBNP(During 6 months of following up)
- The differences of global circumferential strain, global radial strain, global area strain measured by echocardiography.(At the end of 6-month follow-up compared to the baseline)
- The indexes of E, e', a', tricuspid regurgitation velocity measured by echocardiography.(At the end of 6-month follow-up compared to the baseline)
- The indexe of E/e'measured by echocardiography.(At the end of 6-month follow-up compared to the baseline)
- The indexe of RV fractional area change (FAC) measured by echocardiography.(At the end of 6-month follow-up compared to the baseline)
- The incidences of chest tightness, chest pain and palpitation(During 6 months of following up)
- The incidences of arrhythmia and ST-T changes(During 6 months of following up)
- The indexe of left atrial volume index (LAVI)measured by echocardiography.(At the end of 6-month follow-up compared to the baseline)
- The indexe of TAPSE measured by echocardiography.(At the end of 6-month follow-up compared to the baseline)