MedTrace Logo

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

NCT06187818 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-01-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Crocin

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 \[experimental group: taking saffron total glycoside tablets for 8 days during each chemotherapy period (starting from the day before chemotherapy), 4 tablets/time, 3 times a day; control group: not taking saffron total glycoside tablets during chemotherapy period\]

Sponsors & Collaborators

  • Mei Zhang

    lead OTHER

Principal Investigators

  • Guoming Liu, master · The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)

  • Zhanpeng Zhao, master · The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)

  • Xinlei Zhang, master · The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)

  • Yonghao Li, master · The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)

  • Xuena Zhao, master · The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2026-09-01
Completion
2026-09-01
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06187818 on ClinicalTrials.gov