Clinical trial NCT05504148: Protection of Cardiovascular Function With Crocin in BrEast Cancer Patients Undergoing Radiotherapy and Chemotherapy
Official title: Protection of Cardiovascular Function With Crocin in BrEast Cancer Patients Undergoing Radiotherapy and Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Cancer therapy-related cardiac dysfunction
Crocin
Echocardiography
Speckle tracking technology
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 120
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.

Eligible patients were randomly divided into 1:1 group and divided into crocin group and placebo control group. Both groups of subjects received crocin or placebo on the basis of standard anti-tumor treatment.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The change of LVEF measured by echocardiography
timeFrame: At the end of 6-month follow-up compared to the baseline
measure: The change of GLS measured by echocardiography
timeFrame: At the end of 6-month follow-up compared to the baseline
Secondary outcomes:
measure: The incidences of the increase of serum troponin and/or NT-proBNP
timeFrame: During 6 months of following up
measure: The incidences of chest tightness, chest pain and palpitation
timeFrame: During 6 months of following up
measure: The incidences of arrhythmia and ST-T changes
timeFrame: During 6 months of following up
measure: The differences of global circumferential strain, global radial strain, global area strain measured by echocardiography.
timeFrame: At the end of 6-month follow-up compared to the baseline
measure: The indexes of E, e', a', tricuspid regurgitation velocity measured by echocardiography.
timeFrame: At the end of 6-month follow-up compared to the baseline
measure: The indexe of E/e'measured by echocardiography.
timeFrame: At the end of 6-month follow-up compared to the baseline
measure: The indexe of left atrial volume index (LAVI)measured by echocardiography.
timeFrame: At the end of 6-month follow-up compared to the baseline
measure: The indexe of TAPSE measured by echocardiography.
timeFrame: At the end of 6-month follow-up compared to the baseline
measure: The indexe of RV fractional area change (FAC) measured by echocardiography.
timeFrame: At the end of 6-month follow-up compared to the baseline
measure: The indexe of right ventricular free wall global longitudinal strain (RVGLS) measured by echocardiography.
timeFrame: At the end of 6-month follow-up compared to the baseline
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Mei Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
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