Clinical trial: NCT05504148
Section: Confidentiality
Subsections: Is Personal Information Confidential?

Your medical records (research medical records/CFRs, laboratory tests, etc.) will be kept intact at the hospital where you were treated. The doctor will record the test results on your medical record. Investigators, ethics committees and drug regulatory authorities will be allowed to access your medical records. Any public reporting of the results of this study will not disclose your personal identity. We will make every effort to protect the privacy of your personal medical information to the extent permitted by law.
Clinical trial: NCT05504148
Section: Participant Responsibilities
Subsections: What Will I Need To Do If I Participate In The Study?|Other Things That Require Your Cooperation

Before you are enrolled in the study, your doctor will ask and record your medical history, and perform a physical examination and blood chemistry tests. If you are an eligible enrollee, you may voluntarily participate in the study by signing an informed consent form. If you do not want to participate in the study, we will treat you according to your wishes.  
If you volunteer to participate in the study, the following steps will be followed: After you signed the informed consent, you will be divided into the crocin group or the placebo group according to a random, double-blind, placebo-controlled method. Your initials, gender, age, and other general information will be recorded by the oncologist and coded into follow-up observational follow-up studies. Dosage of crocin group or placebo: 3 times a day, 4 tablets each time. The follow-up period was 6 months. Crocin group: take crocus total glucosides tablets for 8 days during each radiotherapy and chemotherapy (started on the 1st day before radiotherapy/chemotherapy), 4 tablets/time, 3 times a day; Placebo group: take placebo during radiotherapy and chemotherapy for 8 days, start to take 1 day before radiotherapy/chemotherapy, 4 tablets/time, 3 times a day.  
You will be followed up every 3 months for 6 months after you are enrolled in the study. The follow-up time is determined according to the clinical situation. We will ask you whether you have chest tightness, chest pain, palpitation and other special symptoms, conduct routine physical examinations, and record clinical events; In order to monitor the safety of medication, we will collect blood and urine samples at each follow-up after you are enrolled in this study, and measure blood and urine routines, liver and kidney function, and blood sugar indicators; ask and record the medical history. Adverse reactions and severity. Carry out appropriate laboratory tests when necessary; In order to observe the end points and evaluate the efficacy, we will perform echocardiography, electrocardiogram, dynamic electrocardiogram, serum troponin, NT-ProBNP and other tests, calculate the relevant ultrasound indicators and electrocardiogram indicators, and compare the differences between the groups. If there is any abnormality during the follow-up period, the medication and follow-up methods can be adjusted according to the doctor's order. The inspection and treatment expenses needed during the normal treatment period are paid by yourselves.  
After all patients were enrolled and followed up for 6 months, the study was terminated and unblinded, and the follow-up continued to 1 year, and transthoracic echocardiography was performed.

You must come to the hospital at the follow-up time agreed between your doctor and you.  
Your follow-up is very important, because your doctor will determine whether the treatment you are receiving is really working and whether there are any adverse effects, and guide you in time. You must take the medicine as directed by your doctor.  
Possible adverse reactions, risks, discomfort and inconvenience of participating in the
Clinical trial: NCT05504148
Section: Participant's Rights
Subsections: Statement Of Consent

I have read the above description of this study and have had the opportunity to discuss and ask questions about the study with my doctor. All the questions I raised got a satisfactory reply.  
I am aware of the possible risks and benefits of participating in this study. I
understand that participation in the study is voluntary, I confirm that I have had sufficient time to consider this, and understand that:
- I can always ask my doctor for more information. - I can withdraw from this study at any time without discrimination or retaliation, and my medical treatment and rights will not be affected.  
I also know that if I drop out of the study in the middle of the study, especially due to drug reasons, if I tell the doctor about the changes in my condition and complete the corresponding physical examination and physical and chemical examination, it will be very beneficial to the whole study.  
If I need to take any other medication due to the change in my condition, I will seek the doctor's advice beforehand, or tell the doctor truthfully afterwards.  
I consent to the review of my research data by the Ethics Committee of the Drug Administration or the sponsor's representative.  
I will get a signed and dated copy of the informed consent form. In the end, I decided to agree to participate in this study and pledged to do my best to follow my doctor's orders.  
Patient signature_______________ Date:____, ____   
I confirm that the details of this trial, including its rights and possible benefits and risks, have been explained to the patient and given a copy of the signed informed consent.  
Doctor's signature:______________ Date:____, ____  
  
Doctor's work phone:
Clinical trial: NCT05504148
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Explanation Of The Cost Of Participating In The Trial

During your participation in this trial, you do not need to pay for the examinations such as electrocardiogram, dynamic electrocardiogram, echocardiography, etc. in the 3rd month and 6th month after enrollment. Crocin tablets and placebo were provided by Reyoung Pharmaceutical Co., Ltd. free of charge.
Clinical trial: NCT05504148
Section: Purpose of Research
Subsections: Research

Gastrointestinal discomfort may occasionally occur when taking saffron total glucoside tablets, and the symptoms may disappear after stopping the drug.  
If you experience any discomfort during the study, or new changes in your condition, or any unforeseen circumstances, whether or not related to the study, you should promptly notify your doctor, who will make a judgment and give appropriate medical treatment . During the study, you need to visit the hospital on time for follow-up and do some examinations, which take up some of your time and may also cause trouble or inconvenience to you.
Clinical trial: NCT05504148
Section: Voluntary Participation
Subsections: Who Is Suitable For Participating In The Research|Who Should Not Participate In The Research:

A total of 120 breast cancer patients undergoing chemotherapy in our hospital were included in this study.  
All participants must meet the following criteria:
(i) Age 25-80 years old, female; (ii) Patients diagnosed with breast cancer by histopathology;
(iii) Patients who plan to receive adjuvant radiotherapy, chemotherapy or combined adjuvant trastuzumab or pertuzumab targeted therapy; (iv) Patients who was to complete at least 6 cycles of treatment after enrollment;

(i) Pregnant or breastfeeding women; (ii) Patients with poor echocardiographic image quality;
(iii) Persistent atrial fibrillation and severe arrhythmia affect the collection and analysis of ultrasound data;
(iv) Patients who are participating in other clinical studies.