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

Prostate Cancer Clinical Trial

— COMRADE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03017417
• Other study ID #: STH19598
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 8, 2017
• Est. completion date: June 2020

Study information

• Verified date: August 2018
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant

Intervention

Other:
• Exercise Intervention
Various exercise tests
• standard of care
standard treatment

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospital NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield Hallam University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants recruited who complete the intervention		16 Weeks
Secondary	Number of participants who show improvement in the Physical function assessments		16 weeks
Secondary	number of participants who show improvement from treatment as shown by a DEXA scan		16 weeks
Secondary	number of participants who show an increase in Muscle hypertrophy following intervention assessment		16 weeks
Secondary	number of participants who show increases in Muscle Strength following intervention assessment		16 weeks
Secondary	number of participants who show a higher score on Quality of life assessments following intervention		16 weeks
Secondary	number of participants who adhere to the Diet diaries		16 weeks