Effects of Carvedilol on Cardiotoxicity in Cancer Patients Submitted to Anthracycline Therapy
Status:
Recruiting
Trial end date:
2024-12-30
Target enrollment:
Participant gender:
Summary
Neoplasia is the main cause of general death in the Brazilian population. In 2016, they were
responsible for approximately 211,343 (16%) deaths, followed by cardiovascular diseases
(12.6%). Despite the high mortality rate of neoplasia, oncological treatment have advanced
substantially in recent decades improving the prognosis of patients. However, growing
evidence suggest that some oncological agents may induce significant toxicity that may play a
major role in the quality of life, morbidity and mortality. The cardiovascular system is
often negatively affected with cancer therapy, predisposing several patients to stop
appropriate treatments or to have cardiovascular events related to the cardiotoxicity. The
most typical manifestation of cardiotoxicity and related consequences (heart failure) are
related to the use of anthracyclines. Anthracyclines are part of the chemotherapy regimen for
solid tumors and hematological neoplasms in children and adults, and are associated with an
increase in life expectancy. Carvedilol is an α and β-blocker that also has antioxidant
properties. Preliminary studies have shown that carvedilol and its metabolites prevent lipid
peroxidation, inhibit the formation and inactivate free radicals, in addition to preventing
the depletion of endogenous antioxidants, such as vitamin E. These effects would potentially
prevent anthracycline injury but definitive evidence is still needed. This is a multi-center,
double-blind, randomized, placebo-controlled study that aims to establish the efficacy of
carvedilol for the primary prevention of left ventricular systolic dysfunction in cancer
patients obtained with anthracycline chemotherapy, in different schedules and doses.