Protection of Cardiovascular Function With Crocin in BrEast Cancer Patients Undergoing Radiotherapy and Chemotherapy (ProtECtion)

Shandong University

Status: Enrolling

Conditions: Breast Cancer

Treatments: Drug: Placebo; Drug: crocin

Study type: Interventional

Funder types: Other

Identifiers

NCT05504148

6010121027

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 25-80 years old, female;
2. Patients diagnosed with breast cancer by histopathology;
3. Patients who plan to receive adjuvant radiotherapy/chemotherapy or combined adjuvant trastuzumab or pertuzumab targeted therapy;
4. Patients who completed at least 6 cycles of treatment after enrollment;

Exclusion criteria

1. pregnant or breastfeeding women;
2. Patients with poor echocardiographic image quality;
3. Persistent atrial fibrillation and severe arrhythmia affect the collection and analysis of ultrasound data;
4. Patients who are participating in other clinical studies.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Crocin group

Experimental group

Description:

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.

Treatment:

Drug: crocin

placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo