Malignant neoplasm of breast. Malignant neoplasm of breast
Conditions
Interventions
Intervention 1: Intervention group: In addition to standard chemotherapy with doxorubicin, this group receives oral empagliflozin at a dose of 10 mg daily. Empagliflozin is a selective SGLT2 inhibitor
Sponsors
Kermanshah University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The patient has breast cancer. The patient is a candidate for doxorubicin-containing chemotherapy. The patient is aged 18 years or older. The patient has an ECOG performance status of 0–2. The patient has a recently confirmed diagnosis of breast cancer.
Exclusion criteria
Exclusion criteria: History of breast cancer. Previous treatment with anthracyclines. Previous use of medications known to cause cardiomyopathy. Diagnosis of diabetes mellitus. History of chest radiotherapy. The patient has left ventricular dysfunction or cardiomyopathy. Significant coronary artery disease. Presence of arrhythmia such as atrial fibrillation. Symptomatic hypotension or blood pressure less than 90 mmHg. Liver enzymes more than three times the upper limit of normal. GFR less than 20 mL/min or requirement for dialysis. Concomitant use of ACE inhibitors. Concomitant use of angiotensin receptor blockers (ARBs). Gestational diabetes. Hypersensitivity to SGLT2 inhibitors. Use of an SGLT2 inhibitor within the past 3 months. Participation in another clinical study simultaneously. Inability to assess left ventricular function. History of heart failure. Significant valvular heart disease. Severe renal failure. Concomitant use of beta-blockers. Breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Left Ventricular Ejection Fraction (LVEF) measured by transthoracic echocardiography from the start of chemotherapy until the end of doxorubicin treatment. Timepoint: Week 0 (Baseline): Before initiation of the first cycle of doxorubicin-based chemotherapy. Week 6: After receiving approximately two cycles of chemotherapy. Week 12: At the end of the doxorubicin treatment course. Week 16 (Follow-up): Four weeks after completion of treatment to assess the persistence of changes. Method of measurement: Two-dimensional transthoracic echocardiography using the Simpson’s biplane technique (recommended by cardiology guidelines), performed by an echocardiography specialist blinded to treatment allocation, with LVEF recorded in the study database at each time point.;Incidence of significant decrease in left ventricular systolic function, defined as a =10% reduction in LVEF from baseline, reaching below 50% during the chemotherapy period. Timepoint: Week 0 (Baseline): Before initiation of the first cycle of doxorubicin-based chemotherapy. Week 6: After receiving approximately two cycles of chemotherapy. Week 12: At the end of the doxorubicin treatment course. Week 16 (Follow-up): Four weeks after completion of treatment to assess the persistence of changes. Method of measurement: Calculation of LVEF by echocardiography using the Simpson method, with comparison of LVEF at each time point to the baseline value.;Change in serum Cardiac Troponin levels from baseline until the end of doxorubicin chemotherapy. Timepoint: Week 0 (Baseline): Before initiation of the first cycle of doxorubicin-based chemotherapy. Week 6: After receiving approximately two cycles of chemotherapy. Week 12: At the end of the doxorubicin treatment course. Week 16 (Follow-up): Four weeks after completion of treatment to assess the persistence of changes. Method of measurement: Blood sampling and measurement using the high-sensitivity cardiac troponin (hs-cTn) assay, with all tests performed in a si | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse effects associated with empagliflozin use. Timepoint: Week 0 (Baseline): Before initiation of the first cycle of doxorubicin-based chemotherapy. Week 6: After receiving approximately two cycles of chemotherapy. Week 12: At the end of the doxorubicin treatment course. Week 16 (Follow-up): Four weeks after completion of treatment to assess the persistence of changes. Method of measurement: Systematic and regular recording of adverse events at each clinical visit using standardized Adverse Event Reporting Forms by the study physician or nurse. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamid Noori
Kermanshah University of Medical Sciences
Outcome results
None listed