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

NCT ID: NCT03017417

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-08
• Study Completion Date: 2018-12-31

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.

Conditions

Prostatic Neoplasms, Castration-Resistant; Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: OTHER

Various exercise tests

standard of care arm

• standard treatment
• exercise advice
• Questionnaires

Group Type: ACTIVE_COMPARATOR

standard of care

Intervention Type: OTHER

standard treatment

Interventions

Exercise Intervention

Various exercise tests

Intervention Type: OTHER

standard of care

standard treatment

Intervention Type: OTHER

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.

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Hallam University

OTHER

Sponsor Role: collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sheffield Teaching Hospital NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

STH19598

Identifier Type: -

Identifier Source: org_study_id