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

Study of Crocin on Cardiac Function Protection in Patients With Breast Cancer Undergoing Neoadjuvant Chemotherapy Based on Color Doppler Ultrasound Combined With Myocardial Zymogram

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Crocin

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250013
      • The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital in Shandong Province)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Female patients with breast cancer aged ≥ 20 years and ≤ 80 years, with informed consent and meeting the treatment standard of neoadjuvant chemotherapy scheme.
2. Patients who plan to receive neoadjuvant chemotherapy based on anthracycline drugs (such as erythromycin, doxorubicin, epirubicin, pyranomycin, idabicin, pentorubicin, and mitoxantrone).
3. No treatment for breast cancer before enrollment, such as chemotherapy, targeted therapy and endocrine therapy.
4. 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.
5. All patients have normal lung function, liver and kidney function.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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]
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.	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]
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: Mei Zhang
• Investigators: Principal Investigator: Guoming Liu, 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: Xinlei Zhang, 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: Xuena Zhao, master, The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: December 17, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2023006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No