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

Breast Cancer Clinical Trial

— ProtECtion  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05504148
• Other study ID #: 6010121027
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2021
• Est. completion date: September 25, 2023

Study information

• Verified date: July 2022
• Source: Qilu Hospital of Shandong University
• Contact: Mei Zhang, PhD
• Phone: +86-18560086629
• Email: daixh[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 25, 2023
• Est. primary completion date: June 25, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• crocin
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.
• Placebo
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

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

References & Publications (17)

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* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 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.	At the end of 6-month follow-up compared to the baseline
Primary	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.	At the end of 6-month follow-up compared to the baseline
Secondary	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.	During 6 months of following up
Secondary	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	During 6 months of following up
Secondary	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.	During 6 months of following up
Secondary	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.	At the end of 6-month follow-up compared to the baseline
Secondary	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.	At the end of 6-month follow-up compared to the baseline
Secondary	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.	At the end of 6-month follow-up compared to the baseline
Secondary	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.	At the end of 6-month follow-up compared to the baseline
Secondary	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.	At the end of 6-month follow-up compared to the baseline
Secondary	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.	At the end of 6-month follow-up compared to the baseline
Secondary	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.	At the end of 6-month follow-up compared to the baseline