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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms, Castration-Resistant Prostate Cancer Other: Exercise Intervention Other: standard of care Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A COMbined progRamme of Exercise and Dietary ADvice in mEn With Castrate Resistant Prostate Cancer - COMRADE Trial
Actual Study Start Date : February 8, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

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Arms and Interventions
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Arm Intervention/treatment
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
 Other: Exercise Intervention
Various exercise tests
Active Comparator: standard of care arm
  • standard treatment
  • exercise advice
  • Questionnaires
 Other: standard of care
standard treatment


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

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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017417


Locations
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United Kingdom
Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield Hallam University
More Information
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03017417    
Other Study ID Numbers: STH19598
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases