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

September 21, 2022 updated by: Qilu Hospital of Shandong University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Crocin group
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.
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_COMPARATOR: placebo group
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
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of LVEF measured by echocardiography
Time Frame: 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.
At the end of 6-month follow-up compared to the baseline
The change of GLS measured by echocardiography
Time Frame: 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.
At the end of 6-month follow-up compared to the baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidences of the increase of serum troponin and/or NT-proBNP
Time Frame: 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.
During 6 months of following up
The incidences of chest tightness, chest pain and palpitation
Time Frame: During 6 months of following up
The differences in the incidence of chest tightness, chest pain and palpitation between the two groups
During 6 months of following up
The incidences of arrhythmia and ST-T changes
Time Frame: During 6 months of following up
Differences between the two groups in the incidences of arrhythmia and ST-T changes displayed by dynamic electrocardiogram.
During 6 months of following up
The differences of global circumferential strain, global radial strain, global area strain measured by echocardiography.
Time Frame: 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.
At the end of 6-month follow-up compared to the baseline
The indexes of E, e', a', tricuspid regurgitation velocity measured by echocardiography.
Time Frame: 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.
At the end of 6-month follow-up compared to the baseline
The indexe of E/e'measured by echocardiography.
Time Frame: 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.
At the end of 6-month follow-up compared to the baseline
The indexe of left atrial volume index (LAVI)measured by echocardiography.
Time Frame: 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.
At the end of 6-month follow-up compared to the baseline
The indexe of TAPSE measured by echocardiography.
Time Frame: 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.
At the end of 6-month follow-up compared to the baseline
The indexe of RV fractional area change (FAC) measured by echocardiography.
Time Frame: 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.
At the end of 6-month follow-up compared to the baseline
The indexe of right ventricular free wall global longitudinal strain (RVGLS) measured by echocardiography.
Time Frame: 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.
At the end of 6-month follow-up compared to the baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 29, 2021

Primary Completion (ANTICIPATED)

June 25, 2023

Study Completion (ANTICIPATED)

September 25, 2023

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

August 14, 2022

First Posted (ACTUAL)

August 17, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6010121027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share the study protocol,statistical Analysis Plan (SAP)and Informed Consent Form (ICF)of this research.

IPD Sharing Time Frame

The sharing time period is 6 months to 1 year after the data is released.

IPD Sharing Access Criteria

Share IPD under the conditions of protecting the privacy of patients and ensuring the safety of all diseases.

It is necessary to contact the researcher and open the sharing authority after the researcher's consent.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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