US-based cancer research and treatment organisation City of Hope, in collaboration with the Children’s Oncology Group (COG), has reported data from a clinical trial of carvedilol for reducing the risk of developing heart failure in childhood cancer survivors.
The double-blind, randomised Phase IIb trial involved 182 participants across 30 COG-member hospitals in the US and Canada.
These subjects were administered low doses of carvedilol or a placebo for two years.
In the trial, no substantial differences in side effects were reported between the carvedilol and placebo arms.
In addition, carvedilol was observed to be well-tolerated in trial subjects.
Although the goal of reducing heart muscle thinning and chamber enlargement was not met, improvements were observed in left ventricular end-systolic wall stress, an early biomarker of deteriorating heart health.
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By GlobalDataThe trial also indicated that carvedilol, a medication used to relax blood vessels, is safe for childhood cancer survivors and may improve key markers of heart injury caused by exposure to chemotherapy.
Anthracycline, a class of chemotherapy, poses a long-term risk of heart failure, where the heart gradually loses its ability to pump sufficient blood.
City of Hope Children’s Cancer Center Barron Hilton Chair in Pediatrics Saro Armenian said: “The greatest benefit was seen in participants who were very long-term survivors, as well as in those who were highly adherent to the study medication.
“Moreover, of the eight patients who developed clinically significant decline in heart function while on the study, six were randomised to placebo and two were receiving carvedilol.
“Our research sets the stage for a Phase III clinical trial that may demonstrate a significant benefit for certain patients who are at an especially high risk of irreversible heart function decline after completion of cancer therapy.”