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Completed

NCT Number: NCT03017417

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

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.

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Key information

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Sheffield Teaching Hospital NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise intervention

Other

Various exercise tests

Standard of care

Other

standard treatment

Primary outcomes

  1. Number of participants recruited who complete the intervention

    Time frame: 16 Weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • Sheffield Hallam University

Registry information

Official study title

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

Acronym: COMRADE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 11, 2017
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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