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

Primary Purpose

Prostatic Neoplasms, Castration-Resistant, Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise Intervention
standard of care
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prostatic Neoplasms, Castration-Resistant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Sheffield Teaching Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise Intervention arm

standard of care arm

Arm Description

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

standard treatment exercise advice Questionnaires

Outcomes

Primary Outcome Measures

Number of participants recruited who complete the intervention

Secondary Outcome Measures

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

Full Information

First Posted
November 14, 2016
Last Updated
August 3, 2018
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Sheffield Hallam University
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1. Study Identification

Unique Protocol Identification Number
NCT03017417
Brief Title
A COMbined progRamme of Exercise and Dietary ADvice in mEn With Castrate Resistant Prostate Cancer
Acronym
COMRADE
Official Title
A COMbined progRamme of Exercise and Dietary ADvice in mEn With Castrate Resistant Prostate Cancer - COMRADE Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 8, 2017 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Sheffield Hallam University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Castration-Resistant, Prostate Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Intervention arm
Arm Type
Experimental
Arm Description
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
Arm Title
standard of care arm
Arm Type
Active Comparator
Arm Description
standard treatment exercise advice Questionnaires
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Various exercise tests
Intervention Type
Other
Intervention Name(s)
standard of care
Intervention Description
standard treatment
Primary Outcome Measure Information:
Title
Number of participants recruited who complete the intervention
Time Frame
16 Weeks
Secondary Outcome Measure Information:
Title
Number of participants who show improvement in the Physical function assessments
Time Frame
16 weeks
Title
number of participants who show improvement from treatment as shown by a DEXA scan
Time Frame
16 weeks
Title
number of participants who show an increase in Muscle hypertrophy following intervention assessment
Time Frame
16 weeks
Title
number of participants who show increases in Muscle Strength following intervention assessment
Time Frame
16 weeks
Title
number of participants who show a higher score on Quality of life assessments following intervention
Time Frame
16 weeks
Title
number of participants who adhere to the Diet diaries
Time Frame
16 weeks

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Sheffield Teaching Hospital NHS Foundation Trust
City
Sheffield
State/Province
South Yorkshire
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no plan to share data

Learn more about this trial

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

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