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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crocin group | Experimental | 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. |
|
| placebo group | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| crocin | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The incidences of chest tightness, chest pain and palpitation |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mei Zhang, PhD | Contact | +86-18560086629 | daixh@vip.sina.com | |
| Xiaoling Liu, PhD | Contact | +86-18560086718 | xiaolingliusdu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Mei Zhang, PhD | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27567406 | Background | Zamorano JL, Lancellotti P, Rodriguez Munoz D, Aboyans V, Asteggiano R, Galderisi M, Habib G, Lenihan DJ, Lip GYH, Lyon AR, Lopez Fernandez T, Mohty D, Piepoli MF, Tamargo J, Torbicki A, Suter TM; ESC Scientific Document Group. 2016 ESC Position Paper on cancer treatments and cardiovascular toxicity developed under the auspices of the ESC Committee for Practice Guidelines: The Task Force for cancer treatments and cardiovascular toxicity of the European Society of Cardiology (ESC). Eur Heart J. 2016 Sep 21;37(36):2768-2801. doi: 10.1093/eurheartj/ehw211. Epub 2016 Aug 26. No abstract available. | |
| 28751851 |
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We plan to share the study protocol,statistical Analysis Plan (SAP)and Informed Consent Form (ICF)of this research.
The sharing time period is 6 months to 1 year after the data is released.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2020 | Aug 4, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 18, 2020 | Aug 4, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C029036 | crocin |
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Inclusion criteria:
Exclusion criteria:
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.
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| Placebo | Drug | 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 |
|
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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 |
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| 42253929 | Derived | Liu X, Li M, Song W, Zhang Y, Bao W, Liu C, Zhang Y, Liu Q, Zhang C, Zhang Y, Li L, Zhang M. Short-Term, Cycle-Synchronized Adjunctive Therapy With Crocus Total Glucosides Tablets for Cardiac Protection Against Cancer Therapy-Related Cardiac Dysfunction in Breast Cancer Patients: A Randomized, Double-Blind, Placebo-Controlled Trial. MedComm (2020). 2026 May 28;7(6):e70780. doi: 10.1002/mco2.70780. eCollection 2026 Jun. |
| D017437 |
| Skin and Connective Tissue Diseases |