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IRCT20250526065902N2 IRCT 2025-11-15 Babol University of Medical Sciences Evaluation of the Protective Effect of Empagliflozin on Doxorubicin- induced Cardiotoxicity in Breast Cancer patients Evaluation of the Protective Effect of Empagliflozin on Doxorubicin- induced Cardiotoxicity in Breast Cancer patients; A Randomized Clinical Trial 2025-10-23 anticipated 152 Recruiting https://irct.ir/trial/86872 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: To randomize patients into two treatment groups with drug (A) and placebo (B), the permuted block randomization method is used. The block size is 4 and the ratio of groups in each block is (1:1). The generation of the random sequence is designed by the methodologist and is performed using the online software Seed envelope.com. In order to conceal the treatment process, a random code is assigned to each of the treatments generated in the above random sequence and written on the cans containing the drug and placebo. After the patients are allocated, the above code is entered on the file, Blinding description: The drug and placebo are completely similar in color, smell, and taste, and the patient, doctor, and evaluator will not know the type of drug. If side effects are observed, the drug code of the same person will be reopened. Otherwise, the codes will be reopened at the end of the study and after analysis. The placebo is manufactured by Dr. Abidi's company in the same packaging, shape, and weight as empagliflozin tablets and is available to the participating pharmacist. Patients go to the pharmacy based on the code assigned to them, which the pharmacist is unaware of, and receive the placebo. 3 Heart failure. Intervention 1: Intervention group: The intervention group, or those receiving empagliflozin, will take a 10 mg empagliflozin tablet daily for 2 months (equivalent to 4 courses of doxorubicin treatment) during the course of conventional chemotherapy for breast cancer treatment until one week after the last chemotherapy session. Intervention 2: Control group: The control group, or placebo group, takes a placebo compound daily for 2 months during the course of receiving conventional chemotherapy for breast cancer treatment until one week after the last chemotherapy session. Yes - There is a plan to make this available What will be shared: The participant data file, study protocol, statistical analysis map, and clinical study report will be published in the form of an article. When: After the article is published To whom: Public Conditions: The data can be used if the article is referenced. Where to obtain: The information published in the relevant article can be accessed by sending an email to the corresponding author. How to obtain: They can be accessed by sending an email to the author responsible for the article and explaining the reason for using the documentation. Comments:
public Sahar Khosravi
Ganj Afrooz
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 9591 saharkhosravi77@yahoo.com Babol University of Medical Sciences scientific Sahar Khosravi
Kheshavarz
Babol Iran (Islamic Republic of) 4717647745 +98 11 3233 1305 s.khosravi@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Patients with newly diagnosed breast cancer, stage 1 to 3, who are candidates for a chemotherapy regimen containing doxorubicin. Reading and signing the informed consent form to participate in the clinical trial People over the age of 18. People who are able to consume food. Negative pregnancy test in women of childbearing age 18 years no limit Female A history of cancer in the past that has received cardiotoxic drugs such as doxorubicin History of chest radiotherapy LVEF less than 50% before starting treatment Being treated for heart failure and taking medications to treat heart failure History of congenital heart disease or history of coronary artery disease History of more than moderate valvular heart disease based on history and records History of hypertension or history of symptomatic hypotension or SBP less than 100 on the first or second visit History of atrial fibrillation History of cardiomyopathy and use of heart failure medications based on the medical history in the file History of stroke Cognitive and neurological disorders Simultaneous participation in another clinical trial Allergy to any of the materials used in the trial Liver disease or LFTs greater than 3 times ULN at first visit Kidney failure in the form of a GFR less than 30 or requiring dialysis, diagnosed at the first visit History of diabetic ketoacidosis History of surgery on the gastrointestinal tract or a gastrointestinal disorder that interferes with drug absorption Patients who have used SGLT2I drugs for at least 3 months before referral Alcohol or drug abuse I50 Heart failure Prevention Placebo Intervention group: The intervention group, or those receiving empagliflozin, will take a 10 mg empagliflozin tablet daily for 2 months (equivalent to 4 courses of doxorubicin treatment) during the course of conventional chemotherapy for breast cancer treatment until one week after the last chemotherapy session. Control group: The control group, or placebo group, takes a placebo compound daily for 2 months during the course of receiving conventional chemotherapy for breast cancer treatment until one week after the last chemotherapy session. Changes in echocardiographic patterns in strain echocardiography. Timepoint: Before the start of the study and one week after the last chemistry session. Method of measurement: Echocardiography. Cardiac ejection fraction (EF). Timepoint: Before the start of the study and one week after the last chemistry session. Method of measurement: Echocardiography. Babol University of Medical Sciences Approved 2025-10-05 Ethics Committee of Babol University of Medical Sciences Ganj Afrooz Babol Mazandaran Iran (Islamic Republic of)