Exercise for Advanced Prostate Cancer: a Multicomponent Feasibility Trial

NCT03658486 | Completed

• 1 other identifier: B18/15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This feasibility study will investigate whether men with metastatic prostate cancer can take part in and progress through a home-based exercise program. This study will evaluate the effects of exercise on a range of disease and treatment-related outcomes.

Conditions

Prostate Cancer Metastatic; Castration-resistant Prostate Cancer

Keywords

Exercise; Metastatic castrate-resistant prostate cancer

Outcome Measures

Primary Outcomes (5)

• Feasibility - recruitment.

  The number of participants that agree to participate or are excluded.

  At baseline.

• Feasibility - adherence to the exercise intervention.

  Determine the percentage of patients adhering to the program and the weekly behavioral consultation sessions.

  Throughout the 24 week study period.

• Feasibility - attrition rates.

  The number of patients that withdraw.

  Throughout the 24 week study period.

• Feasibility - safety / adverse events.

  Any safety / adverse events, in general or in relation to the exercise program, will be documented by the research team.

  Monitored throughout the 24 week study period.

• Feasibility - patient experience.

  Determined by qualitative evaluation, using semi-structured interviews, to assess experiences, accessibility and acceptability of the exercise intervention.

  Following the study conclusion at 24 weeks.

Secondary Outcomes (10)

• Anthropometric assessment.

  At baseline, 12 and 24 weeks.

• Hip and waist circumference analysis.

  At baseline, 12 and 24 weeks.

• Functional ability assessment.

  At baseline, 12 and 24 weeks.

• Physical fitness assessment.

  At baseline, 12 and 24 weeks.

• Objectively measure of physical activity levels.

  At baseline, 12 and 24 weeks.

Study Arms (1)

Exercise

OTHER

12 weeks of progressive, home-based, moderate intensity, aerobic and strengthening exercise. Aerobic exercise will be completed 5 days per week, commencing with a single 10 minute bout and progressing to 30 minutes of continuous brisk walking at week 12. Strengthening exercises will involve whole body activities and commence with 1 set of each exercise (8-15 repetitions) and progress to 3 sets. The strengthening exercises will gradually progress in difficulty throughout the program.

Other: Exercise

Interventions

Exercise OTHER

Exercise programs will be individually tailored to the capabilities of each participant and gradually progressed accordingly. Each patient will be assigned a moderate intensity walking and strengthening program to complete at home. At baseline, 12 and 24 weeks patients will wear an accelerometer to determine activity levels. At these time points, patients will also complete a physical fitness assessment (timed sit-to-stand and six minute walking tests) and a range of quality of life questionnaires. At baseline, patients will receive a behaviour change consultation and continued support throughout the intervention. Each patient will receive a pedometer during the home-based, unsupervised regime to monitor step count and they are expected to complete a daily physical activity diary. Upon completion of the 24 week follow-up, patients will be invited to partake in semi-structured interviews to determine the effectiveness of the program and their experience throughout.

Exercise

Eligibility Criteria

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

You may qualify if:

• Histologically documented adenocarcinoma of the prostate with progressive systemic metastatic disease despite castrate levels of testosterone (\<50ng/dL).
• At enrolment, patients must have demonstrated progressive disease since the most recent change in therapy.
• Patients must be on ADT with a GnRH agonist/antagonist or prior bilateral orchiectomy. All patients must be on ADT during the study period.
• ≥ 4 weeks since last surgery and fully recovered.
• No known contraindications to moderate intensity exercise such as (but not limited to) brain metastases, acute congestive heart failure, unstable angina, serious or non-healing wound, peripheral neuropathy greater than or equal to Grade 3. Recent myocardial infarction.
• Age ≥ 18 years.
• ECOG performance status 0-2.
• Medical clearance by treating clinician.

You may not qualify if:

• Men currently exceeding ACSM recommended exercise guidelines (150 mins of moderate and/or 60 mins of high intensity exercise per week).
• Men with brain metastases.
• Men with a currently active second malignancy other than non-melanoma skin cancer.
• Congestive heart failure or recent serious cardiovascular event.
• Chest pain brought on by physical activity.

Sponsors & Collaborators

• Queen's University, Belfast: lead
• HSC Public Health Agency: collaborator

Study Sites (1)

Northern Ireland Cancer Centre, Belfast City Hospital

Belfast, BT9 7JL, United Kingdom

Location

Related Publications (1)

• Brown M, Murphy M, McDermott L, McAneney H, O'Sullivan JM, Jain S, Prue G. Exercise for advanced prostate cancer: a multicomponent, feasibility, trial protocol for men with metastatic castrate-resistant prostate cancer (EXACT). Pilot Feasibility Stud. 2019 Aug 16;5:102. doi: 10.1186/s40814-019-0486-6. eCollection 2019.

  PMID: 31428443 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: September 5, 2018
• Study Start: February 19, 2019
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

GB (1)