Funded by a £2.5m award from the National Institute for Health Research (NIHR) and developed in partnership with patients, the STAMINA (Supported exercise training for men with prostate cancer on androgen deprivation therapy) trial will be testing whether a longer-term supported exercise programme – embedded in NHS cancer care and delivered via expert commercial partners in the community – can counter the problems caused by androgen deprivation therapy (ADT).
ADT is the standard treatment for managing advanced prostate cancer but it is associated with significant side effects including: fatigue, depression, sexual dysfunction, cognitive dysfunction (impairment of memory and concentration), increased fat mass and loss of muscle strength. ADT also increases the risk of developing bone fractures, diabetes and heart and circulatory problems.
If found to be clinically effective, STAMINA will be the first evidence-based service of its kind for improving the lives of those living with prostate cancer, with findings applicable across other countries where prostate cancer is prevalent.
Half of all men with prostate cancer will be treated with ADT. Short-term exercise has been shown to help mitigate side-effects of treatment. Current NICE (National Institute of Health and Clinical Excellence) guidance recommends 12 weeks of supervised exercise to combat loss in QoL caused by ADT.[i] However very few treatment centres are currently able to support exercise intervention as a core part of NHS service.
Study Chief Investigator and consultant urological surgeon at Sheffield Teaching Hospitals NHS Foundation Trust, Professor Derek Rosario said of the study: “We have been working in this area for over 10 years now. We have shown that specific targeted exercise training significantly reduces many of the adverse effects caused by ADT as well as improving quality of life in these men. Unless the intervention is embedded within the cancer care of the man and ongoing support is provided though, participation dwindles and the benefits are lost. So finding cost-effective ways of ensuring men on ADT continue with their training programme is essential if we are to reduce the side effects and provide sustained benefits. The NIHR-funded STAMINA study is a novel approach and if the model is successful, it could be applied to a number of long-term health conditions."
Academic lead, Professor Liam Bourke from Sheffield Hallam University said: "This is one of the largest studies of its kind anywhere in the world - it is designed to test fundamentally new ideas about reducing the treatment burden in men with prostate cancer. It's very ambitious but if the results are positive it could offer new ways of looking at treatment across several cancers including breast and colo-rectal."
In STAMINA, NHS staff treating men on ADT for prostate cancer will be able to prescribe a 12 month exercise programme with participants randomised to either NHS best practice (based on NICE guidance) or the experimental intervention. The prescribed exercise programme will be individually-tailored and delivered free of charge in the community by us via our national network of Fitness and Wellbeing clubs. STAMINA will also explore ways to optimise communication between clinical and exercise teams so that men receive the support they need to stick with exercise training for the full prescribed duration. Ultimately, the cluster-randomised trial (cRCT) will involve approximately 1,000 men with prostate cancer on ADT in around 40 NHS sites, with patients randomised to the STAMINA intervention or usual care (1:1).
Dr Davina Deniszczyc, our Charity Director and Primary Medical Director said: “STAMINA aims to generate robust ‘real-world’ evidence that is required to define best practice. We can test whether supported exercise delivered in our clubs can provide value for money in comparison to other community-based exercise interventions.”
Professor Elaine Hay, Professor of Community Rheumatology at Keele University and Director of NIHR Programme Grants for Applied Research, said: “The NIHR chose to fund this large programme of research because of its real potential to combat the loss in quality of life experienced by men on ADT. The approach of offering behaviourally-supported, supervised exercise training embedded into NHS prostate cancer treatment is an exemplar of the complex healthcare problems tackled by the NIHR Programme Grants funding scheme.”
The programme of work has been three years in the design, with significant contribution from other collaborating institutions including: University of Leeds, University of Sheffield, Queen Mary University London, University of Bristol, University of York, Cardiff University, University of Edinburgh and Queen’s University, Belfast.
To find out more about the project and how patients or treatment centres can get involved, visit: www.stamina.org.uk or tweet the STAMINA team @STAMINA_SHU
Last updated Friday 2 November 2018
First published on Friday 2 November 2018