A COMbined progRamme of Exercise and Dietary ADvice in mEn With Castrate Resistant Prostate Cancer (COMRADE)

• ClinicalTrials.gov Identifier: NCT03017417
• Recruitment Status: Unknown
• First Posted: January 11, 2017
• Last Update Posted: August 7, 2018
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborator: Sheffield Hallam University
• Information provided by (Responsible Party): Sheffield Teaching Hospitals NHS Foundation Trust

Tracking Information

• First Submitted Date: November 14, 2016
• First Posted Date: January 11, 2017
• Last Update Posted Date: August 7, 2018
• Actual Study Start Date: February 8, 2017
• Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 9, 2017): Number of participants recruited who complete the intervention [ Time Frame: 16 Weeks ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 9, 2017)

• 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 Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A COMbined progRamme of Exercise and Dietary ADvice in mEn With Castrate Resistant Prostate Cancer
• 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 Description: 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• Prostatic Neoplasms, Castration-Resistant
• Prostate Cancer

Intervention

• Other: Exercise Intervention
  Various exercise tests
• Other: standard of care
  standard treatment

Study Arms

• Experimental: Exercise Intervention arm

  exercise training intervention to include:

  • DEXA scan will collect data on via a full body scan to determine post-cranial appendicular whole body LM, whole body fat free mass (FFM) and whole body FM.
  • Muscle Strength assessment
  • Physical function assessment
  • Questionnaires and diet diaries
  Intervention: Other: Exercise Intervention
• Active Comparator: standard of care arm
  • standard treatment
  • exercise advice
  • Questionnaires
  Intervention: Other: standard of care

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: August 3, 2018): 31
• Original Estimated Enrollment (submitted: January 9, 2017): 50
• Estimated Study Completion Date: June 2020
• Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Men with Castrate resistant prostate cancer

• Men with histologically confirmed PCa on long-term ADT with either

  • PSA>2ng/ml above nadir or PSA level that has risen serially on at least two occasions (each at least 4 weeks apart) in the presence of castrate levels of testosterone or;
  • Evidence of symptomatic disease progression whilst undergoing first line androgen deprivation therapy (ADT) in the presence of castrate levels of testosterone or;
  • Radiographic disease progression whilst undergoing first line ADT in the presence of castrate levels of testosterone

Exclusion Criteria:

• • Participation in other trials which might bias the evaluation of the primary objectives of the present study.

  • Current participation in regular physical activity (defined as purposeful physical activity of a moderate intensity for 90 minutes per week for at least six months).
  • Unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers.
  • Uncontrolled painful or unstable bony metastatic lesions.
  • Within two months of invasive surgical treatment (transurethral surgery allowed).
  • Any physical, neurological or psychiatric impairment or disease or other condition that would limit the ability to understand and complete the study assessments and complete the required questionnaires, recall and record of dietary information would be excluded.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT03017417
• Other Study ID Numbers: STH19598
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: no plan to share data

• Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
• Study Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborators: Sheffield Hallam University
• Investigators: Not Provided
• PRS Account: Sheffield Teaching Hospitals NHS Foundation Trust
• Verification Date: August 2018