- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03017417
A COMbined progRamme of Exercise and Dietary ADvice in mEn With Castrate Resistant Prostate Cancer (COMRADE)
August 3, 2018 updated by: Sheffield Teaching Hospitals NHS Foundation Trust
A COMbined progRamme of Exercise and Dietary ADvice in mEn With Castrate Resistant Prostate Cancer - COMRADE Trial
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.
Study Overview
Status
Unknown
Intervention / Treatment
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
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Yorkshire
-
Sheffield, South Yorkshire, United Kingdom
- Sheffield Teaching Hospital NHS Foundation Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise Intervention arm
exercise training intervention to include:
|
Various exercise tests
|
Active Comparator: standard of care arm
|
standard treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants recruited who complete the intervention
Time Frame: 16 Weeks
|
16 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants who show improvement in the Physical function assessments
Time Frame: 16 weeks
|
16 weeks
|
number of participants who show improvement from treatment as shown by a DEXA scan
Time Frame: 16 weeks
|
16 weeks
|
number of participants who show an increase in Muscle hypertrophy following intervention assessment
Time Frame: 16 weeks
|
16 weeks
|
number of participants who show increases in Muscle Strength following intervention assessment
Time Frame: 16 weeks
|
16 weeks
|
number of participants who show a higher score on Quality of life assessments following intervention
Time Frame: 16 weeks
|
16 weeks
|
number of participants who adhere to the Diet diaries
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 8, 2017
Primary Completion (Anticipated)
June 1, 2020
Study Completion (Anticipated)
June 1, 2020
Study Registration Dates
First Submitted
November 14, 2016
First Submitted That Met QC Criteria
January 9, 2017
First Posted (Estimate)
January 11, 2017
Study Record Updates
Last Update Posted (Actual)
August 7, 2018
Last Update Submitted That Met QC Criteria
August 3, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STH19598
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
no plan to share data
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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