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Clinical trial to reduce cardiac damage from breast cancer therapy set to launch in EU

Women receiving breast cancer therapy across six clinical centres in Europe will be enrolled in a study to determine whether behavioural and psychological interventions can reduce the cardiac damage from anti-cancer therapies.

The innovative CARDIOCARE project, which was launched in 2021 by a consortium of European partners including the European Society of Cardiology (ESC), aims to radically change the management of older women with breast cancer by harnessing the expertise of a multidisciplinary team to improve the monitoring, treatment and care these patients receive.

It is already known that breast cancer survivors have an estimated 32% higher risk of cardiovascular disease.

Now, a clinical trial evaluating the impact of behavioural and psychological interventions on quality of life, physical and mental wellbeing, and the cardiotoxic effects of breast cancer treatment will be conducted in 750 patients with breast cancer.

As part of the trial, all patients will receive the CARDIOCARE mobile app, which includes psychological and behavioural elements called ePsycHeart and eHealtHeart. Participants will be randomly allocated to receive both ePsycHeart and eHealtHeart – the intervention group or to receive ePsycHeart only.

ePsycHeart monitors quality of life, mobility and mental health using a wearable chest band heart rate sensor, smartwatch and questionnaires. eHealtHeart encourages patients to adopt behaviours such as physical activity, healthy diet, games to improve memory and changing the home environment to reduce the risk of falls.

A further aim of the trial is the early identification of women with breast cancer who are at the greatest risk of cardiac damage from anti-cancer treatments. The trial will utilise cutting-edge technologies, such as next generation sequencing, to pinpoint changes in gut microbe species that signal damage of the heart and blood vessels before symptoms occur. In addition, artificial intelligence will be used to analyse images of the heart to predict the likelihood of heart damage.

Professor Dimitrios Fotiadis, project coordinator and professor of biomedical engineering at the University of Ioannina in Greece, said: ‘Cardiovascular disease is a devastating complication of anti-cancer treatment that affects physical and mental health. CARDIOCARE will provide women over the age of 65 with breast cancer the tools to improve their physical health and to psychologically adapt to the disease.

‘CARDIOCARE is on track to improve the physical and mental health of older women with breast cancer by detecting the cardiovascular side effects of anti-cancer treatment early and providing digital tools to help patients improve their mental and physical wellbeing.‘

A 2022 study found that a time-restricted eating pattern for older breast cancer survivors with cardiovascular risk factors is able to reduce their overall risk of CVD.

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