Exercise Training as a Novel Primary Therapy for Men With Localised Prostate Cancer
NCT02409212 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2019-01-30
Summary
Study design: The study is a two arm randomised controlled trial (randomisation ratio 1:1) comparing an aerobic exercise training intervention to usual care plus exercise advice. The primary outcome is the feasibility of the intervention as novel primary therapy in men with localised prostate cancer.
Conditions
Interventions
- BEHAVIORAL
-
Aerobic exercise training
Aerobic exercise training will be undertaken for 12 months, combining supervised and independent exercise sessions. Behaviour change counselling will take place bi-monthly, either via face to face sessions during exercise or via telephone by study clinical exercise specialist according to participant preference.
- BEHAVIORAL
-
Placebo surveillance and written exercise guidelines
Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer
Sponsors & Collaborators
-
Sheffield Hallam University
collaborator OTHER -
University of Sheffield
collaborator OTHER -
Queen Mary University of London
collaborator OTHER -
University College London Hospitals
collaborator OTHER -
Institute of Cancer Research, United Kingdom
collaborator OTHER -
Sheffield Teaching Hospitals NHS Foundation Trust
lead OTHER
Principal Investigators
-
Derek Rosario, MD · University of Sheffield / Sheffield Teaching Hospitals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2018-12-31
- Completion
- 2018-12-31
Countries
- United Kingdom
Study Locations
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