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 | Active Not Recruiting FDA Drug

• 1 other identifier: 2023006
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Cardiac ultrasound LVEF, GLS

  LVEF and GLS levels measured by echocardiography before and after treatment (within and between groups).

  December 2024

Secondary Outcomes (5)

• Abnormal rate of electrocardiogram

  December 2024

• Overall radial strain of the heart

  December 2024

• Cardiac asynchrony index

  December 2024

• myocardial enzymes

  December 2024

• Symptoms of cardiac discomfort

  December 2024

Study Arms (4)

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

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

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.

Interventions

Crocin DRUG

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 1; experience group 2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mei Zhang: lead

Study Sites (1)

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

Jinan, Shandong, 250013, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

crocin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Guoming Liu, 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

• Xinlei Zhang, 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

• Xuena Zhao, master

  The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 3, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

CN (1)