Clinical Trial: A COMbined progRamme of Exercise and Dietary ADvice in mEn With Castrate Resistant Prostate Cancer

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A COMbined progRamme of Exercise and Dietary ADvice in mEn With Castrate Resistant Prostate Cancer - COMRADE Trial

Brief Summary: The proposed study will assess the feasibility of an exercise and dietary intervention in men with castrate resistant prostate cancer with secondary outcomes assessing improvements in physical functioning, fatigue, quality of life, and body composition.The study will have 2 arms, with one set of participants randomized to resistance exercise training intervention plus dietary advice and the other arm will be standard of care plus exercise advice.

Detailed Summary: 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 castrate resistant prostate cancer with secondary outcomes assessing improvements in physical functioning, fatigue, quality of life, and body composition.
Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Current Primary Outcome: Number of participants recruited who complete the intervention [ Time Frame: 16 Weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants who show improvement in the Physical function assessments [ Time Frame: 16 weeks ]
  • number of participants who show improvement from treatment as shown by a DEXA scan [ Time Frame: 16 weeks ]
  • number of participants who show an increase in Muscle hypertrophy following intervention assessment [ Time Frame: 16 weeks ]
  • number of participants who show increases in Muscle Strength following intervention assessment [ Time Frame: 16 weeks ]
  • number of participants who show a higher score on Quality of life assessments following intervention [ Time Frame: 16 weeks ]
  • number of participants who adhere to the Diet diaries [ Time Frame: 16 weeks ]


Original Secondary Outcome: Same as current

Information By: Sheffield Teaching Hospitals NHS Foundation Trust

Dates:
Date Received: November 14, 2016
Date Started: January 2017
Date Completion: June 2020
Last Updated: January 9, 2017
Last Verified: January 2017