Protection of Cardiovascular Function With Crocin in BrEast Cancer Patients Undergoing Radiotherapy and Chemotherapy
- Registration Number
- NCT05504148
- Lead Sponsor
- Qilu Hospital of Shandong University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo group Placebo 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 Crocin group crocin 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.
- Primary Outcome Measures
Name Time Method The change of LVEF measured by echocardiography 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 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.
- Secondary Outcome Measures
Name Time Method 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 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.
The incidences of the increase of serum troponin and/or NT-proBNP During 6 months of following up 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.
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 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.
The indexes of E, e', a', tricuspid regurgitation velocity measured by echocardiography. At the end of 6-month follow-up compared to the baseline 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.
The indexe of E/e'measured by echocardiography. At the end of 6-month follow-up compared to the baseline 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.
The indexe of RV fractional area change (FAC) measured by echocardiography. At the end of 6-month follow-up compared to the baseline 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.
The incidences of chest tightness, chest pain and palpitation During 6 months of following up The differences in the incidence of chest tightness, chest pain and palpitation between the two groups
The incidences of arrhythmia and ST-T changes During 6 months of following up Differences between the two groups in the incidences of arrhythmia and ST-T changes displayed by dynamic electrocardiogram.
The indexe of left atrial volume index (LAVI)measured by echocardiography. At the end of 6-month follow-up compared to the baseline 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.
The indexe of TAPSE measured by echocardiography. At the end of 6-month follow-up compared to the baseline 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.
Trial Locations
- Locations (1)
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China