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IRCT20231014059713N1 IRCT 2023-11-18 Tehran University of Medical Sciences Efficacy of empagliflozin in prevention of Doxorubicin-induced cardiotoxicity in patients with breast cancer Efficacy of empagliflozin in prevention of Doxorubicin-induced cardiotoxicity in patients with breast cancer and receiving AC regimen (Cyclophosphamide + Doxorubicin): a randomized, placebo-controlled, double-blind trial 2023-11-22 anticipated 64 Complete https://irct.ir/trial/73139 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are randomly assigned to two groups of intervention (receiving chemotherapy regimen + empagliflozin) and control (receiving chemotherapy regimen + placebo) by using block randomization. This is a double-blinded trial {the patient, researcher (student) and the doctors} and the randomization will be performed by the project executor based on double or quadruple random tables and on each box, a number will be registered, the contents of which will be unknown, and will be given to the researcher and then to the patient, Blinding description: Participants in the study, the physician who introduced them to the research team, the cardiologist who is responsible for measuring echocardiographic parameters of patients in both groups, and the laboratory staff who are responsible for measuring cardiac biomarkers in patients and the student who makes the arrangements (as a researcher) are blinded in this study. The project executor by using block randomization method (using two or four tables), assign a number randomly to each box containing the medicine or placebo, that is given to the researcher and the patient. 3 Condition 1: Breast cancer. Condition 2: Drug-induced cardiomyopathy. Intervention 1: Intervention group: A group in which patients receive Empagliflozin drug produced by abidi pharmaceutical at a dose of 10 mg once in the day along with chemotherapy. The patient will receive this drug from the first day of chemotherapy until one week after the last session. The duration of medication will be 49 or 70 days, depending on the patient's chemotherapy regimen. Intervention 2: Control group: A group in which patients receive Placebo produced by abidi pharmaceutical once in the day along with chemotherapy. The patient will receive placebo from the first day of chemotherapy until one week after the last session. The duration of medication will be 49 or 70 days, depending on the patient's chemotherapy regimen. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is not necessary
public Ehsan Shabani
No. 1, Nahid Ave., Marzdaran Blvd., Ashrafi Esfahani Expy
Tehran Iran (Islamic Republic of) 1461674569 +98 21 4424 3529 eshabani@razi.tums.ac.ir Tehran University of Medical Sciences scientific Ehsan Shabani
No. 1, Nahid Ave., Marzdaran Blvd., Ashrafi Esfahani Expy
Tehran Iran (Islamic Republic of) 1461674569 +98 21 4424 3529 eshabani@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) A known case of breast cancer and candidate for receiving AC regimen Signing a written informed consent to participate in the study Patient age ≥ 18 Ability to take oral medicine ECOG performance status less than or equal to 2 18 years no limit Female A history of breast cancer or a history of receiving chemotherapy regimen containing anthracycline or other chemotherapy drugs causing cardiomyopathy before entering the study Inability to assess left ventricular (LV) function Previous history of chest radiation therapy Evidence of heart failure or left ventricular dysfunction based on echocardiography Diagnosis or history of cardiomyopathies Significant coronary artery disease (history of coronary stenting or stenosis based on previous angiography, history of known IHD or MI) Severe valvular heart disease Cardiac arrhythmia such as atrial fibrillation Symptomatic hypotension or blood pressure less than 90 mmHg at the first visit Liver enzymes more than 3 times ULN before entering the study Significant renal failure (GFR less than 20 ml/min/1.73m2 with CKD-EPI formula) or need for dialysis Simultaneous use of other drugs that can affect parameters of the study (such as ACEi, ARB, beta blockers) Diabetes Pregnancy Breastfeeding Hypersensitivity to SGLT2 inhibitor drugs History of treatment with SGLT2 inhibitors during the last 3 months before the start of the study Participation in other clinical studies simultaneously C50 I42.7 Malignant neoplasm of breast Cardiomyopathy due to drug and external agent Prevention Placebo Intervention group: A group in which patients receive Empagliflozin drug produced by abidi pharmaceutical at a dose of 10 mg once in the day along with chemotherapy. The patient will receive this drug from the first day of chemotherapy until one week after the last session. The duration of medication will be 49 or 70 days, depending on the patient's chemotherapy regimen. Control group: A group in which patients receive Placebo produced by abidi pharmaceutical once in the day along with chemotherapy. The patient will receive placebo from the first day of chemotherapy until one week after the last session. The duration of medication will be 49 or 70 days, depending on the patient's chemotherapy regimen. LVEF (Left ventricular ejection fraction) : The left ventricular drain fraction or the amount of blood pumped from the left ventricle with each contraction. Timepoint: Once at the beginning and once a week after the last chemotherapy session. Method of measurement: Using echocardiography performed by a cardiologist. GLS (Global longitudinal strain): A sensitive criterion used by echocardiography to measure myocardial deformity and left ventricular contractile strength and can aid in the early diagnosis of cardiotoxicity. A decrease of more than 15% compared to the beginning or an absolute value of -19% after the start of anthracyclines is associated with a significant increase in the risk of future LVEF reduction. Timepoint: At the beginning and one week after the last chemotherapy session. Method of measurement: Echocardiography by a cardiologist. Troponin I: One of the three types of troponin present in the body that is more specific to the myocardium of the heart and as a marker of the heart, can help diagnose myocardial damage. This enzyme increases within a few hours after heart damage and can last for a long time. Remain in my head for 10-14 days. Timepoint: Once at the beginning and twice at one week after the second and last session of chemotherapy. Method of measurement: Blood sampling and blood level measurement by laboratory. NT-proBNP: It is one of the types of natriuretic peptides that indicates the filling pressure inside the heart and the stress of the walls of the ventricles, which is used to diagnose heart failure. Timepoint: Once at the beginning and twice at one week after the second and last session of chemotherapy. Method of measurement: Blood sampling and blood level measurement by laboratory. Tehran University of Medical Sciences Approved 2023-11-11 The Institute of Pharmaceutical Sciences (TIPS) of the Tehran University of Medical Sciences The Institute of Pharmaceutical Sciences (TIPS), Tehran University of Medical Sciences, Faculty of Pharmacy, Poursina Avenue Tehran Tehran Iran (Islamic Republic of)