COMRADE Exercise and CRPC
Research type
Research Study
Full title
A COMbined progRamme of exercise and dietary ADvice in mEn with castrate resistant prostate cancer - COMRADE trial
IRAS ID
215735
Contact name
Liam Bourke
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS FT
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Background: Although there have been advances in recent years, therapeutic options remain limited for men with castrate resistant prostate cancer (CRPC). There is an unmet clinical need for interventions which can improve quality of life, functional capacity and cancer related fatigue. Adjunctive exercise therapy could be a potentially effective treatment for these men. A growing body of evidence has demonstrated numerous benefits in physiological and psychosocial outcomes in men with advanced prostate cancer. Further, there is observational evidence linking physical activity with reduced disease specific mortality after a diagnosis of cancer. Observational data also indicates that preserving skeletal muscle mass can improve responses to chemotherapy. The proposed study will assess the feasibility of an exercise and dietary intervention in men with CRPC with secondary outcomes assessing improvements physical function, fatigue, quality of life and body composition.
Aim: To determine the feasibility of a 16 week program of exercise training and dietary advice in men with CRPC.
Methods: The proposed study will be a two arm randomised controlled trial. Fifty men with CRPC will be randomised to the exercise and dietary advice intervention for 16 weeks or usual care. The primary outcome will be the feasibility of the intervention including recruitment rate, adherence and attrition due to the intervention, loss to follow-up and adverse event rate. Feasibility outcomes will be assessed using standard methods for rates and proportions. Secondary outcomes will include physical function, fatigue, quality of life and body composition.
How will the results of this research be used? If we successfully demonstrate that a program of exercise and dietary advice is feasible in men with CRPC we will seek to assess clinical effectiveness in a full scale trial with a view to establishing exercise as an efficacious and cost-effective therapy.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
16/NE/0382
Date of REC Opinion
6 Jan 2017
REC opinion
Further Information Favourable Opinion