Brief Summary Anthracyclines (e.g., doxorubicin) are effective anticancer agents but can cause dose-dependent, often irreversible cardiotoxicity via oxidative stress, mitochondrial dysfunction, and cardiomyocyte apoptosis. Trastuzumab is also associated with left-ventricular dysfunction, typically reversible. The original protocol planned cohorts for both drug classes; however, no trastuzumab patients were enrolled due to feasibility, and the final study focused exclusively on anthracycline-treated patients. Dapagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor approved for diabetes and heart failure, has cardioprotective properties beyond glycemic control (reduced oxidative stress, inflammation, and fibrosis). We evaluated whether dapagliflozin mitigates anthracycline-induced cardiotoxicity. This randomized, double-blind, placebo-controlled trial enrolled 90 patients receiving anthracycline-based chemotherapy. Participants were randomized 1:1 to: 1. dapagliflozin 10 mg orally once daily for 4 months plus standard chemotherapy; or 2. matching placebo once daily for 4 months plus standard chemotherapy. Primary outcome: change in left ventricular ejection fraction (LVEF) and diastolic function (e.g., E/A ratio, e'/E/e', diastolic dysfunction grade) from baseline to 16 weeks after chemotherapy initiation, measured by echocardiography. Secondary outcomes: Troponin I, NT-proBNP, Galectin-3, CA 15-3, renal indices (creatinine, BUN, eGFR), and incidence of symptomatic cardiac dysfunction (e.g., heart failure, arrhythmias, myocardial infarction). Safety events related to chemotherapy or dapagliflozin were recorded and graded by CTCAE. Assessments were performed at two time points only-baseline (pre-chemotherapy) and 16 weeks after initiation of chemotherapy; adverse events were collected continuously through the 16-week study period. If effective, dapagliflozin could represent a practical cardioprotective strategy for patients receiving anthracyclines, potentially improving cardiovascular outcomes without compromising cancer therapy.
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Left Ventricular Function (Systolic and Diastolic)
Timeframe: Evaluated at baseline and 4 months after initiation of chemotherapy.