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

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ClinicalTrials.gov Identifier: NCT03017417
Recruitment Status : Unknown
Verified August 2018 by Sheffield Teaching Hospitals NHS Foundation Trust.
Recruitment status was:  Active, not recruiting
First Posted : January 11, 2017
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
Sheffield Hallam University
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE November 14, 2016
First Posted Date  ICMJE January 11, 2017
Last Update Posted Date August 7, 2018
Actual Study Start Date  ICMJE February 8, 2017
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2017)
Number of participants recruited who complete the intervention [ Time Frame: 16 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A COMbined progRamme of Exercise and Dietary ADvice in mEn With Castrate Resistant Prostate Cancer
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Prostatic Neoplasms, Castration-Resistant
  • Prostate Cancer
Intervention  ICMJE
  • Other: Exercise Intervention
    Various exercise tests
  • Other: standard of care
    standard treatment
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 3, 2018)
31
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2017)
50
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03017417
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Plan Description: no plan to share data
Responsible Party Sheffield Teaching Hospitals NHS Foundation Trust
Study Sponsor  ICMJE Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators  ICMJE Sheffield Hallam University
Investigators  ICMJE Not Provided
PRS Account Sheffield Teaching Hospitals NHS Foundation Trust
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP