Clinical trial NCT03017417: A COMbined progRamme of Exercise and Dietary ADvice in mEn With Castrate Resistant Prostate Cancer
Official title: A COMbined progRamme of Exercise and Dietary ADvice in mEn With Castrate Resistant Prostate Cancer - COMRADE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms, Castration-Resistant
Prostate Cancer
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Sheffield Hallam University
First posted: 2017-01-11
Enrollment: 31
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Number of participants recruited who complete the intervention
timeFrame: 16 Weeks
Secondary outcomes:
measure: Number of participants who show improvement in the Physical function assessments
timeFrame: 16 weeks
measure: number of participants who show improvement from treatment as shown by a DEXA scan
timeFrame: 16 weeks
measure: number of participants who show an increase in Muscle hypertrophy following intervention assessment
timeFrame: 16 weeks
measure: number of participants who show increases in Muscle Strength following intervention assessment
timeFrame: 16 weeks
measure: number of participants who show a higher score on Quality of life assessments following intervention
timeFrame: 16 weeks
measure: number of participants who adhere to the Diet diaries
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospital NHS Foundation Trust
state: South Yorkshire
Study officials:
References: