The feasibility of a randomised controlled trial of dietary and physical activity interventions for men with localised prostate cancer: the PrEvENT trial

niversity of Bristol (UK)0 个研究点目标入组 108 人开始时间: 2014年11月17日最近更新: 2021年9月27日

适应症

试验速览

•1. Localised prostate cancer
•2. To be undergoing radical prostatectomy
•3. Be due to receive treatment at the Urology Centre, Southmead Hopsital, North Bristol NHS Trust
•4. Capacity to consent for themselves as judged by a member of the research team with appropriate training and experience
•5. Be aged 18 or over, there is no upper age limit
•6. Have sufficient understanding of the English language, including being able to read and speak English at a basic level

•1. Inability to give informed consent or unavailability for follow-up
•2. Being identified as unsuitable to participate following guidance of their clinician
•3. Co-morbidities which could prevent participation in the intervention (RCT only) ie. this could include uncontrolled congestive heart failure or angina, recent myocardial infarction or breathing difficulties requiring oxygen use or hospitalisation. Additionally, the use of a mobility aid other than a walking stick
•4. Allergies which would prevent participation in the intervention (RCT only) ie. allergy to lycopene
•5. Religious beliefs that constrain them from participating in any aspect of the intervention (RCT only)
•6. Any other additional reason for not being able to participate in any aspect of the intervention (RCT only)
•7. Current heavy consumers of the nutritional element of the intervention, as judged by the research team (RCT only) ie. those who have been taking lycopene supplements daily for more than three months or eat more than five portions of fruit and vegetables every single day
•8. Those who routinely exercise vigorously may not be suitable for the intervention (RCT only)

发起方

niversity of Bristol (UK)