Phase II clinical trial to test simple intervention to help cancer survivors avoid heart failure
A simple intervention, similar to the tension applied to the arm during a blood pressure reading, is being tested in a Phase II clinical trial to see if it can help cancer patients treated with common chemotherapy drugs, called anthracyclines, avoid heart failure.
The trial is part of the RESILIENCE project, which aims to reduce the incidence of heart failure in cancer survivors. In all, 355 people have already been recruited to the phase II, double-blinded, randomized clinical trial, with 608 expected to take part in total. Patients who will take part are being treated for lymphoma or breast cancer at 22 hospitals in six countries—Spain, Germany, Portugal, Denmark, France, and the Netherlands.
Anthracyclines are highly effective medicines used in chemotherapy to treat several types of cancer, but they can have harmful effects on the heart, also known as cardiotoxicity. This can lead to heart failure in some patients.
"For many patients, the trade-off between cancer and potential heart damage can be horribly stressful. This trial is testing a simple intervention that patients can do themselves in their own home once a week during cancer treatment, to try to reduce their risk of heart damage," explained Professor Borja Ibáñez, coordinator of the RESILIENCE project and Scientific Director of the National Center for Cardiovascular Research in Spain.
"If the trial shows that this intervention reduces heart failure in cancer survivors, it will pave the way for an even larger phase III outcomes clinical trial," Professor Ibáñez continued.
The intervention is called Remote Ischemic Conditioning (RIC) and involves controlled periods of restricting blood flow (ischemia) and restoring blood flow (reperfusion) in a patient's limb. In other applications, it has been shown to help other tissues and organs in the body become more resilient to the damaging impacts of changes in blood flow, such as myocardial infarction or stroke.
The RESILIENCE project will also investigate gender differences in cancer therapy-related heart damage and response to the intervention. In addition, it will test a new MRI scanning protocol that could detect damage to the hearts of cancer patients earlier than with current standards.
"This is the first time an intervention has been offered to cancer patients during their treatment that could reduce their long-term chances of heart failure. The fact that the intervention is non-invasive with no known side-effects is a big bonus," Professor Ibáñez explained. "We have involved patients in the design of this trial, and it has been great to see how enthusiastic cancer patients are to take part and to understand the science behind the study."
"This trial has involved a truly remarkable collaboration between hospitals, research centers, industry partners and clinicians across six countries, alongside the critical role played by the European Society of Cardiology. The scale of this collaboration makes this a unique, landmark study in cardio-oncology," Professor Ibáñez concluded.
About 1 million people in Europe are living with chronic heart failure following cancer therapy-related cardiotoxicity. Of the 4 million Europeans diagnosed with cancer each year, 3 million receive anthracyclines as part of their cancer treatment. Recent research suggests around 35% will develop some form of cardiotoxicity as a result of anthracycline, with around 6% developing moderate to severe cardiotoxicity, which can include heart failure.
Provided by European Society of Cardiology
