AzTrials
AzTrials

Prostate Cancer MetastaticEXACTNCT03658486

Exercise for Advanced Prostate Cancer: a Multicomponent Feasibility Trial

A study testing Exercise in people with Prostate Cancer Metastatic and Castration-resistant Prostate Cancer, run by Queen's University, Belfast at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited Kingdom
Study dates
19 Feb 2019to 31 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Northern Ireland Cancer Centre, Belfast City Hospital

    Belfast, BT9 7JL

Other trials in United Kingdom

About this study

Official title: Exercise for Advanced Prostate Cancer: a Multicomponent Feasibility Trial in Men With Metastatic Castrate-Resistant Prostate Cancer

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.

Read the detailed description

This 12 week multicomponent, tailored, progressive program will consist of both moderate intensity walking and strengthening exercises at home. This single centre, single arm study will incorporate a behavioural change consultation at baseline and weekly behavioural support throughout. This study will follow-up patients at 24 weeks to determine exercise maintenance. Outcome measures will be completed at baseline, 12 and 24 weeks. A qualitative evaluation will be conducted after the 24 week follow-up to determine impact, patient experience and measures that might assist in refining the program.

Being tested
Exercise
Keywords
Exercise, Metastatic castrate-resistant prostate cancer
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    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.

Study groups in NCT03658486
Study groupRoleWhat they receive
ExerciseOther12 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.
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility - recruitment.

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

    Measured: At baseline.

  2. Feasibility - adherence to the exercise intervention.

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

    Measured: Throughout the 24 week study period.

  3. Feasibility - attrition rates.

    The number of patients that withdraw.

    Measured: Throughout the 24 week study period.

  4. Feasibility - safety / adverse events.

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

    Measured: Monitored throughout the 24 week study period.

  5. Feasibility - patient experience.

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

    Measured: Following the study conclusion at 24 weeks.

Secondary outcomes (10)

  1. Anthropometric assessment.

    Height will be measured in cm and body weight in kg, which will be combined to report BMI in kg/m(squared).

    Measured: At baseline, 12 and 24 weeks.

  2. Hip and waist circumference analysis.

    Hip and waist circumference will be measured in cms.

    Measured: At baseline, 12 and 24 weeks.

  3. Functional ability assessment.

    The amount of repetitions achieved during a 30 second sit-to-stand test will be recorded.

    Measured: At baseline, 12 and 24 weeks.

  4. Physical fitness assessment.

    Distance covered in meters during a six minute walk test will be recorded.

    Measured: At baseline, 12 and 24 weeks.

  5. Objectively measure of physical activity levels.

    Patients will wear an accelerometer for 7 full days.

    Measured: At baseline, 12 and 24 weeks.

  6. Perceived physical activity levels.

    Patients will complete an International Physical Activity Questionnaire (IPAQ-SF). This questionnaire will comprise 4 generic items to obtain comparable health-related physical activity. Patients will detail the number of days, hours and minutes that they undertake (1) vigorous exercise (2) moderate exercise (3) walking exercise and (4) sitting. Total physical activity will be generated and monitored for improvement or decline.

    Measured: At baseline, 12 and 24 weeks.

  7. Cancer-related fatigue by questionnaire.

    Fatigue will be measured by the Functional Assessment of Cancer Therapy - Fatigue (FACIT-Fatigue) questionnaire. Patients will score several fatigue items over the past 7 days on a scale (0 = not at all; 4 = very much), generating a total (0 - 52) with higher scores linked to greater quality of life.

    Measured: At baseline, 12 and 24 weeks.

  8. Quality of life will be measured using a questionnaire.

    Quality of life will be measured by the Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire. Patients will score a series of questions (0 = not at all; 4 = very much) in five sections (physical well-being; social/family well-being; emotional well-being; functional well-being; additional concerns) for the past 7 days. Higher scores will suggest better quality of life.

    Measured: At baseline, 12 and 24 weeks.

  9. Quality of life will be measured using questionnaires.

    Quality of life will be measured by the EuroQOL Five Dimension Questionnaire (EQ5D). Patients will select a level of difficulty (I have no - I have extreme) on that particular days health for mobility, self-care, usual activities, pain / discomfort and anxiety / depression. Patients will then rate 'how good' or 'how bad' their health is on that day using a 100 point scale (0 = worst health you can imagine; 100 = best health you can imagine).

    Measured: At baseline, 12 and 24 weeks.

  10. Pain will be measured through a questionnaire.

    Bone pain will be monitored using the Brief Pain Inventory Short Form (BPI-SF).

    Measured: At baseline, 12 and 24 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2018
  2. Study start19 Feb 2019
  3. Primary completion31 Aug 2022
  4. Study completion31 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03658486
Sponsor's protocol ID
B18/15
Acronym
EXACT
Status last verified
Feb 2024
First submitted
16 Aug 2018
Last updated
16 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31428443

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Prostate Cancer Metastatic and Castration-resistant Prostate Cancer, run by Queen's University, Belfast at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility - recruitment. (time frame: At baseline.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03658486, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in