Protection of Cardiovascular Function With Crocin in BrEast Cancer Patients Undergoing Radiotherapy and Chemotherapy
Status:
Recruiting
Trial end date:
2023-09-25
Target enrollment:
Participant gender:
Summary
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.