Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Mei Zhang

Conditions:

Breast Cancer

Eligibility:

FEMALE

20-80 years

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...

Detailed Description

At present, the commonly used anthracycline antineoplastic drugs in clinic include daunorubicin, doxorubicin, epirubicin, pirarubicin, idabicin, pentarubicin and mitoxantrone, among which doxorubicin ...

Eligibility Criteria

Inclusion

  • Female patients with breast cancer aged ≥ 20 years and ≤ 80 years, with informed consent and meeting the treatment standard of neoadjuvant chemotherapy scheme.
  • Patients who plan to receive neoadjuvant chemotherapy based on anthracycline drugs (such as erythromycin, doxorubicin, epirubicin, pyranomycin, idabicin, pentorubicin, and mitoxantrone).
  • No treatment for breast cancer before enrollment, such as chemotherapy, targeted therapy and endocrine therapy.
  • All patients underwent coarse needle biopsy of breast tumors (axillary lymph node biopsy is required for suspected axillary lymph node metastasis) to determine the status of ER, PR, HER-2, and Ki-67.
  • All patients have normal lung function, liver and kidney function.

Exclusion

  • Cases that do not cooperate and are unwilling to sign informed consent forms.
  • Antitumor therapy, hormone replacement therapy and other breast cancer related treatments were performed before enrollment.
  • Merge any other malignant tumors.
  • Patients with poor image quality in echocardiography.
  • Continuous atrial fibrillation and severe arrhythmia affect ultrasound data collection and analysis.
  • Patients with active infections, a history of HIV, or chronic hepatitis B or C.
  • Patients with abnormal lung function or liver and kidney function.
  • Patients with hemorrhagic diseases.
  • Patients taking other heart protection traditional Chinese patent medicines and simple preparations.
  • Participated in other clinical researchers in the past 3 months.

Key Trial Info

Start Date :

September 1 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 1 2026

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT06187818

Start Date

September 1 2023

End Date

September 1 2026

Last Update

January 3 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital in Shandong Province)

Jinan, Shandong, China, 250013