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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
Take saffron total glucosides tablets for 8 days during each chemotherapy (started on the 1st day before radiotherapy/chemotherapy), 4 tablets/time, 3 times a day.
Take placebo piece during for 8 days during each chemotherapy (started on the 1st day before radiotherapy/chemotherapy), 4 tablets/time, 3 times a day
Qilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGThe change of LVEF measured by echocardiography
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.
Time frame: At the end of 6-month follow-up compared to the baseline
The change of GLS measured by echocardiography
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.
Time frame: At the end of 6-month follow-up compared to the baseline
The incidences of the increase of serum troponin and/or NT-proBNP
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 between the two groups during follow-up.
Time frame: During 6 months of following up
The incidences of chest tightness, chest pain and palpitation
The differences in the incidence of chest tightness, chest pain and palpitation between the two groups
Time frame: During 6 months of following up
The incidences of arrhythmia and ST-T changes
Differences between the two groups in the incidences of arrhythmia and ST-T changes displayed by dynamic electrocardiogram.
Time frame: During 6 months of following up
The differences of global circumferential strain, global radial strain, global area strain measured by echocardiography.
Differences between groups in the difference in global circumferential strain, global radial strain, global area strain measured by echocardiography at the end of the experiment compared to baseline.
Time frame: At the end of 6-month follow-up compared to the baseline
The indexes of E, e', a', tricuspid regurgitation velocity measured by echocardiography.
Differences between groups in the difference in the indexes of left ventricular diastolic function measured by echocardiography at the end of the experiment compared to baseline.
Time frame: At the end of 6-month follow-up compared to the baseline
The indexe of E/e'measured by echocardiography.
Differences between groups in the difference in the indexes of left ventricular diastolic function measured by echocardiography at the end of the experiment compared to baseline.
Time frame: At the end of 6-month follow-up compared to the baseline
The indexe of left atrial volume index (LAVI)measured by echocardiography.
Differences between groups in the difference in the indexes of left ventricular diastolic function measured by echocardiography at the end of the experiment compared to baseline.
Time frame: At the end of 6-month follow-up compared to the baseline
The indexe of TAPSE measured by echocardiography.
Differences between groups in the difference in the right ventricular function monitoring indicators measured by echocardiography at the end of the experiment compared to baseline.
Time frame: At the end of 6-month follow-up compared to the baseline
The indexe of RV fractional area change (FAC) measured by echocardiography.
Differences between groups in the difference in the right ventricular function monitoring indicators measured by echocardiography at the end of the experiment compared to baseline.
Time frame: At the end of 6-month follow-up compared to the baseline
The indexe of right ventricular free wall global longitudinal strain (RVGLS) measured by echocardiography.
Differences between groups in the difference in the right ventricular function monitoring indicators measured by echocardiography at the end of the experiment compared to baseline.
Time frame: At the end of 6-month follow-up compared to the baseline
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