Breast CancerNCT06187818
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
An observational study of Breast Cancer, run by Mei Zhang at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Crocin
- Type of treatment
- Pill or oral medicine
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Sep 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital in Shandong Province)
Jinan, Shandong, 250013
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Crocin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrocinDrug
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]
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac ultrasound LVEF, GLS
LVEF and GLS levels measured by echocardiography before and after treatment (within and between groups).
Measured: December 2024
Secondary outcomes (5)
Abnormal rate of electrocardiogram
Comparison of abnormal electrocardiogram rates before and after treatment (within and between groups).
Measured: December 2024
Overall radial strain of the heart
Overall radial strain measured by ultrasound before and after treatment (intra group and inter group).
Measured: December 2024
Cardiac asynchrony index
Cardiac asynchrony index before and after treatment (within and between groups).
Measured: December 2024
myocardial enzymes
Comparison of myocardial enzyme spectrum results before and after treatment (within and between groups).
Measured: December 2024
Symptoms of cardiac discomfort
The frequency and duration of chest tightness, chest pain, and palpitations.
Measured: December 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Sep 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Mei Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mei Zhang, Qianfoshan Hospital
- Investigators
- Guoming Liu, master, Principal investigator, The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)Zhanpeng Zhao, master, Principal investigator, The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)Xinlei Zhang, master, Principal investigator, The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)Yonghao Li, master, Principal investigator, The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)Xuena Zhao, master, Principal investigator, The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187818
- Sponsor's protocol ID
- 2023006
- Status last verified
- Dec 2023
- First submitted
- 17 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Crocin on Cardiac Function Protection in Patients With Breast Cancer Undergoing Neoadjuvant Chemotherapy Based on Color Doppler Ultrasound Combined With Myocardial Zymogram
- ClinicalTrials.gov ID
- NCT06187818
- Acronym / sponsor ID
- 2023006
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mei ZhangUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| experience group 1 | – | Drug: CrocinTake 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. |
| experience group 2 | – | Drug: CrocinTake 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. |
| 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrocinAccording 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] | Drug | experience group 1, experience group 2 |
Primary outcome
Cardiac ultrasound LVEF, GLS
Time frame: December 2024
LVEF and GLS levels measured by echocardiography before and after treatment (within and between groups).
5 secondary outcomes
Abnormal rate of electrocardiogram
Time frame: December 2024
Overall radial strain of the heart
Time frame: December 2024
Cardiac asynchrony index
Time frame: December 2024
myocardial enzymes
Time frame: December 2024
Symptoms of cardiac discomfort
Time frame: December 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guoming Liu, master principal investigator
The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)
Zhanpeng Zhao, master principal investigator
The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)
Xinlei Zhang, master principal investigator
The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Mei Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac ultrasound LVEF, GLS (time frame: December 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.