Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT06187818
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Follow up Study of Crocin on Cardiac Function Protection in Patients With Breast Cancer Undergoing Neoadjuvant Chemotherapy Based on Color Doppler Ultrasound Combined With Myocardial Zymogram
Sponsor:
Mei Zhang
Organization:
Study Overview
Official Title:
Study of Crocin on Cardiac Function Protection in Patients With Breast Cancer Undergoing Neoadjuvant Chemotherapy Based on Color Doppler Ultrasound Combined With Myocardial Zymogram
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: