To hear about similar clinical trials, please enter your email below
Trial Title:
Protection of Cardiovascular Function With Crocin in BrEast Cancer Patients Undergoing Radiotherapy and Chemotherapy
NCT ID:
NCT05504148
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast cancer
Cancer therapy-related cardiac dysfunction
Crocin
Echocardiography
Speckle tracking technology
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
crocin
Description:
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.
Arm group label:
Crocin group
Intervention type:
Drug
Intervention name:
Placebo
Description:
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
Arm group label:
placebo group
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.
Criteria for 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.
Gender:
Female
Minimum age:
25 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Recruiting
Contact:
Last name:
Lijuan Bu, PhD
Phone:
+86-18560088816
Email:
qlyykyc@163.ocm
Start date:
March 29, 2021
Completion date:
September 25, 2023
Lead sponsor:
Agency:
Qilu Hospital of Shandong University
Agency class:
Other
Source:
Qilu Hospital of Shandong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05504148
