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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250526065902N2
Enrollment
152
Registered
2025-11-15
Start date
2025-10-23
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure. Heart failure

Interventions

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 treatmen

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Cardiac ejection fraction (EF). Timepoint: Before the start of the study and one week after the last chemistry session. Method of measurement: Echocardiography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSahar Khosravi

Babol University of Medical Sciences

saharkhosravi77@yahoo.com+98 11 3219 9591

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026