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Foreign data show that: 1807 tumor patients were followed up for 7 years, 33% of them died of heart disease and 51% of them died of the tumor itself. In China, the number of cancer patients undergoing chemotherapy is increasing rapidly every year. How to protect the heart of chemotherapy patients from the damage of chemotherapy drugs (especially anthracyclines) is a problem that clinicians must face.In order to further confirm the clinical efficacy and value of saffron total glycosides tablets in the protection of central function of breast cancer neoadjuvant patients with anthracycline based chemotherapy scheme, the project plans to follow up and observe the research of saffron total glycosides on the protection of cardiac function of breast cancer neoadjuvant patients with chemotherapy based on cardiac color ultrasound combined with myocardial zymography, and randomly group to confirm the effectiveness of saffron total glycosides tablets on cardiac protection, Based on the clinical observation and research on the effect of traditional Chinese medicine on the cardiotoxicity of anthracycline drugs, confirm its efficacy, explore the mechanism of cardiac protection, and explore the drug use method of synergism and toxicity reduction of anthracycline drugs in combination with this active ingredient.
At present, the commonly used anthracycline antineoplastic drugs in clinic include daunorubicin, doxorubicin, epirubicin, pirarubicin, idabicin, pentarubicin and mitoxantrone, among which doxorubicin is one of the most commonly used antineoplastic drugs. However, anthracyclines have dose dependent and cumulative cardiotoxicity. In patients receiving doxorubicin (DOX) treatment, nearly 10% of patients will have cardiac complications after stopping chemotherapy for nearly 10 years, and its cardiac toxicity may even threaten life, which limits its clinical application.
Crocus sativus glycoside, as the main active ingredient of Crocus sativus L., has a wide range of pharmacological effects, and it has a good effect on cardiovascular system.
Based on the clinical observation and research on the effect of traditional Chinese medicine on the cardiotoxicity of anthracycline drugs, confirm its efficacy, explore the mechanism of cardiac protection, and explore the drug use method of synergism and toxicity reduction of anthracycline drugs in combination with this active ingredient. In this study, 120 patients with breast cancer undergoing neoadjuvant chemotherapy (including anthracycline) were randomly enrolled, and the cardiac baseline assessment was done. The clinical efficacy of crocin in protecting heart function of breast cancer patients undergoing neoadjuvant chemotherapy was evaluated according to clinical symptoms, cardiac color ultrasound, electrocardiogram and myocardial enzyme spectrum, To further verify the clinical application value and social and economic benefits of saffron, the heart protecting active ingredient in saffron, in the aspect of heart protection in neoadjuvant chemotherapy for breast cancer, and further promote the use and broaden the clinical application range of traditional Chinese medicine. Prevention is more important than treatment, which is in line with the national concept of "preventing disease" of traditional Chinese medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experience group 1 | Take 4 total glucosides of crocin tablets (Ruiyang Pharmaceutical Co., Ltd.) 3 times a day for 8 days (the day before chemotherapy) during each chemotherapy.Previous history of heart disease. |
| |
| experience group 2 | Take 4 total glucosides of crocin tablets (Ruiyang Pharmaceutical Co., Ltd.) 3 times a day for 8 days (the day before chemotherapy) during each chemotherapy.No previous heart disease. |
| |
| Control group 1 | Did not take crocine tablets during chemotherapy.Previous history of heart disease. | ||
| Control group 2 | Did not take crocine tablets during chemotherapy.No previous heart disease. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crocin | Drug | According to the patient's condition, tolerance level, and personal preference, the dosage of medication was selected. During chemotherapy, the total anthocyanin tablets were divided into an experimental group (experimental group 1 and experimental group 2 based on previous heart disease) and a control group (control group 1 and control group 2 based on previous heart disease), 30 cases in each group [experimental group: taking saffron total glycoside tablets for 8 days during each chemotherapy period (starting from the day before chemotherapy), 4 tablets/time, 3 times a day; control group: not taking saffron total glycoside tablets during chemotherapy period] |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac ultrasound LVEF, GLS | LVEF and GLS levels measured by echocardiography before and after treatment (within and between groups). | December 2024 |
| Measure | Description | Time Frame |
|---|---|---|
| Abnormal rate of electrocardiogram | Comparison of abnormal electrocardiogram rates before and after treatment (within and between groups). | December 2024 |
| Overall radial strain of the heart | Overall radial strain measured by ultrasound before and after treatment (intra group and inter group). |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer patients with neoadjuvant chemotherapy based on anthracycline drugs who were hospitalized in the breast surgery department of Shandong Qianfoshan Hospital from the time when the ethical approval document was obtained to December 2024.
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| Name | Affiliation | Role |
|---|---|---|
| Guoming Liu, master | The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital) | Principal Investigator |
| Zhanpeng Zhao, master | The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital) | Principal Investigator |
| Xinlei Zhang, master | The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital) | Principal Investigator |
| Yonghao Li, master | The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital) | Principal Investigator |
| Xuena Zhao, master | The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital in Shandong Province) | Jinan | Shandong | 250013 | China |
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|
| December 2024 |
| Cardiac asynchrony index | Cardiac asynchrony index before and after treatment (within and between groups). | December 2024 |
| myocardial enzymes | Comparison of myocardial enzyme spectrum results before and after treatment (within and between groups). | December 2024 |
| Symptoms of cardiac discomfort | The frequency and duration of chest tightness, chest pain, and palpitations. | December 2024 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C029036 | crocin |
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