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

NCT03017417 | Completed

• 1 other identifier: STH19598
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms, Castration-Resistant; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of participants recruited who complete the intervention

  16 Weeks

Secondary Outcomes (6)

• Number of participants who show improvement in the Physical function assessments

  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

• 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

Study Arms (2)

Exercise Intervention arm

EXPERIMENTAL

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

Other: Exercise Intervention

standard of care arm

ACTIVE COMPARATOR

* standard treatment * exercise advice * Questionnaires

Other: standard of care

Interventions

Exercise Intervention OTHER

Various exercise tests

Exercise Intervention arm

standard of care OTHER

standard treatment

standard of care arm

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Sheffield Hallam University: collaborator

Study Sites (1)

Sheffield Teaching Hospital NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant; Prostatic Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: January 11, 2017
• Study Start: February 8, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)