]>
IRCT20200427047219N1 IRCT 2020-05-10 Zanjan University of Medical Sciences Effects of quince fruit syrup on reduction of cardiotoxicity induced by Herceptin in patients with breast cancer Evaluation of the effects of quince (Cydonia Oblonga Mill.) fruit syrup on reduction of cardiotoxicity induced by Trastuzumab (Herceptin) in patients with breast cancer 2020-07-05 anticipated 30 Complete https://irct.ir/trial/47667 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple accidental, Blinding description: Patients and researchers will be unaware of the contents of the bottles during the study and whether participants will receive the extract or placebo. Containers containing placebo and extract are coded by a third party and delivered to patients. 1-2 Patients with breast cancer who are taking herceptin. Intervention group: Patients with breast cancer who take herceptin and take syrup with it. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mohammad Reza
Department of Pharmacology and Toxicology, School of Pharmacy, Zanjan University of Medical Sciences, 45139-56184 Zanjan, Iran
Zanjan Iran (Islamic Republic of) 45139-56184 +98 24 3347 3638 eskandarimr@zums.ac.ir Zanjan University of Medical Sciences scientific Mohammad Reza Eskandari
Department of Pharmacology and Toxicology, School of Pharmacy, Zanjan University of Medical Sciences, Zanjan, Iran, Postal Code: 45139-56184
Zanjan Iran (Islamic Republic of) 45139-56184 +98 24 3347 3635 eskandarimr@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Breast cancer in the early stages of the disease HER2 positive Women over 18 years Lack of underlying heart problems The desire to participate in the study 38 years no limit Female Suffering from other cancers Thyroid disorders Kidney disorders Getting other vitamin or mineral supplements Patients with lower body mass index18/5 Lack of desire to continue participating in the project Prevention Intervention group: Patients with breast cancer who take herceptin and take syrup with it 1. Determining the effect of quince syrup on cardiac function-related factors (left ventricular emptying fraction) in patients with breast cancer receiving fruit syrup by comparison with patients with breast cancer receiving placebo. 2- Determining the effect of quince syrup on the findings of ECG in patients with breast cancer receiving the syrup compared to patients receiving placebo.3. Determining the effect of quince syrup on the plasma levels of troponin I in patients with breast cancer receiving fruit syrup who have evidence of cardiomyopathy by comparing them with patients with breast cancer receiving placebo who have evidence of cardiomyopathy.4. Determining the effect of quince syrup on creatinine plasma plasma levels in patients with breast cancer receiving fruit syrup by comparing with patients with breast cancer receiving placebo. Timepoint: Patients will drink the syrup daily with some water for three months. The placebo will appear in the same bottles as the intervention group. The syrup bottles and placebo are given to patients on a monthly basis, and the researcher will follow up on the consumption or report possible side effects on the phone and on a weekly basis. Method of measurement: Blood sampling to check the blood levels of biomarkers related to cardiac poisoning caused by prescribing herceptin in this disease will be done at the beginning and end of the study, ie 3 months later. 1- Receiving fruit syrup has an effect on heart function factors (left ventricular emptying fraction) in patients with breast cancer. 2- Receiving fruit syrup has an effect on the findings of ECG in patients with breast cancer. Fruit syrup affects the amount of troponin I in patients with breast cancer who have had cardiomyopathy. 4. Fruit syrup intake affects the amount of creatine kinase in patients with breast cancer. Timepoint: At the beginning of the study (before the start of the intervention) and 3 months after the start of the syrup. Method of measurement: Ventricular drainage fraction by echocardiography and troponin I by immunoenzymatic fluorescent assay. Zanjan University of Medical Sciences Approved 2020-01-16 Zanjan University of Medical Sciences, Ethics Committee زنجان، بلوار آزادی، ستاد مرکزی دانشگاه علوم پزشکی زنجان، ساختمان دوم، طبقه سوم، معاونت تحقیقات و فناوری ZANJAN Zanjan Iran (Islamic Republic of)