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

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

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:

  • 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
Various exercise tests
Active Comparator: standard of care arm
  • standard treatment
  • exercise advice
  • Questionnaires
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.

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

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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