Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06187818 |
| Other study ID # |
2023006 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2023 |
| Est. completion date |
September 1, 2026 |
Study information
| Verified date |
December 2023 |
| Source |
Qianfoshan Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
