A prospective study to evaluate the efficacy and safety of vitamin E and levocarnitine prophylaxis against doxorubicin-induced cardiotoxicity in adult breast cancer patients

Abstract

Background Doxorubicin induces acute and chronic cardiotoxicity. This study is aimed to evaluate the efficacy and safety of vitamin E and levocarnitine (EL) as cardioprotective agents against acute doxorubicin cardiotoxicity in female adult breast cancer patients. Methods A prospective, randomized controlled study was conducted in patients treated with doxorubicin and cyclophosphamide (AC). Patients were randomly assigned to EL plus AC or AC alone for the duration of 4 cycles. Cardiac enzymes (B-type natriuretic peptide, creatine kinase, troponin I (Trop)) and cardiac events were monitored during treatment to evaluate the cardioprotective efficacy of EL. Results Seventy-four patients were recruited and received four cycles of chemotherapy. The intervention group ( n = 35) showed a significant reduction in both the B-type natriuretic peptide and creatine kinase cardiac enzymes compared to the control group ( n = 39). The median (IQR) change for BNP was 0.80 (0.00–4.00) for IG versus 1.80 (0.40–3.60) for CG groups ( p < 0.001); creatine kinase was −0.08 (−0.25–0.05) for IG versus 0.20 (0.05–0.50) for CG ( p < 0.001). The addition of EL decreased the cardiac events by 24.2% ( p = 0.02). All adverse events were tolerable and manageable. Conclusion This study supports the addition of EL as prophylaxis against acute doxorubicin cardiotoxicity and it was also very well tolerated by a majority of the patients. The co-administration of EL at higher doxorubicin (240 mg/m2) dose should be further investigated.