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

Not Applicable

Completed

• Conditions: Prostatic Neoplasms, Castration-Resistant; Prostate Cancer
• Interventions: Other: Exercise Intervention; Other: standard of care

• Registration Number: NCT03017417
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2017-01-09
• Study First Posted: 2017-01-11
• Study Start: 2017-02-08
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Intervention arm	Exercise Intervention	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 of care arm	standard of care	* standard treatment * exercise advice * Questionnaires

Primary Outcome Measures

Name	Time	Method
Number of participants recruited who complete the intervention	16 Weeks

Secondary Outcome Measures

Name	Time	Method
number of participants who show increases in Muscle Strength following intervention assessment	16 weeks
number of participants who show a higher score on Quality of life assessments following intervention	16 weeks
Number of participants who show improvement in the Physical function assessments	16 weeks
number of participants who adhere to the Diet diaries	16 weeks
number of participants who show improvement from treatment as shown by a DEXA scan	16 weeks
number of participants who show an increase in Muscle hypertrophy following intervention assessment	16 weeks

Trial Locations

Locations (1)

Sheffield Teaching Hospital NHS Foundation Trust; 🇬🇧 Sheffield, South Yorkshire, United Kingdom