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Exercise for Advanced Prostate Cancer: a Multicomponent Feasibility Trial (EXACT)

Primary Purpose

Prostate Cancer Metastatic, Castration-resistant Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise
Sponsored by
Queen's University, Belfast
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostate Cancer Metastatic focused on measuring Exercise, Metastatic castrate-resistant prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Northern Ireland Cancer Centre, Belfast City HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Exercise

Arm Description

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.

Outcomes

Primary Outcome Measures

Feasibility - recruitment.
The number of participants that agree to participate or are excluded.
Feasibility - adherence to the exercise intervention.
Determine the percentage of patients adhering to the program and the weekly behavioral consultation sessions.
Feasibility - attrition rates.
The number of patients that withdraw.
Feasibility - safety / adverse events.
Any safety / adverse events, in general or in relation to the exercise program, will be documented by the research team.
Feasibility - patient experience.
Determined by qualitative evaluation, using semi-structured interviews, to assess experiences, accessibility and acceptability of the exercise intervention.

Secondary Outcome Measures

Anthropometric assessment.
Height will be measured in cm and body weight in kg, which will be combined to report BMI in kg/m(squared).
Hip and waist circumference analysis.
Hip and waist circumference will be measured in cms.
Functional ability assessment.
The amount of repetitions achieved during a 30 second sit-to-stand test will be recorded.
Physical fitness assessment.
Distance covered in meters during a six minute walk test will be recorded.
Objectively measure of physical activity levels.
Patients will wear an accelerometer for 7 full days.
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.
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.
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.
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).
Pain will be measured through a questionnaire.
Bone pain will be monitored using the Brief Pain Inventory Short Form (BPI-SF).

Full Information

First Posted
August 16, 2018
Last Updated
November 30, 2021
Sponsor
Queen's University, Belfast
Collaborators
HSC Public Health Agency
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1. Study Identification

Unique Protocol Identification Number
NCT03658486
Brief Title
Exercise for Advanced Prostate Cancer: a Multicomponent Feasibility Trial
Acronym
EXACT
Official Title
Exercise for Advanced Prostate Cancer: a Multicomponent Feasibility Trial in Men With Metastatic Castrate-Resistant Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University, Belfast
Collaborators
HSC Public Health Agency

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Metastatic, Castration-resistant Prostate Cancer
Keywords
Exercise, Metastatic castrate-resistant prostate cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility - recruitment.
Description
The number of participants that agree to participate or are excluded.
Time Frame
At baseline.
Title
Feasibility - adherence to the exercise intervention.
Description
Determine the percentage of patients adhering to the program and the weekly behavioral consultation sessions.
Time Frame
Throughout the 24 week study period.
Title
Feasibility - attrition rates.
Description
The number of patients that withdraw.
Time Frame
Throughout the 24 week study period.
Title
Feasibility - safety / adverse events.
Description
Any safety / adverse events, in general or in relation to the exercise program, will be documented by the research team.
Time Frame
Monitored throughout the 24 week study period.
Title
Feasibility - patient experience.
Description
Determined by qualitative evaluation, using semi-structured interviews, to assess experiences, accessibility and acceptability of the exercise intervention.
Time Frame
Following the study conclusion at 24 weeks.
Secondary Outcome Measure Information:
Title
Anthropometric assessment.
Description
Height will be measured in cm and body weight in kg, which will be combined to report BMI in kg/m(squared).
Time Frame
At baseline, 12 and 24 weeks.
Title
Hip and waist circumference analysis.
Description
Hip and waist circumference will be measured in cms.
Time Frame
At baseline, 12 and 24 weeks.
Title
Functional ability assessment.
Description
The amount of repetitions achieved during a 30 second sit-to-stand test will be recorded.
Time Frame
At baseline, 12 and 24 weeks.
Title
Physical fitness assessment.
Description
Distance covered in meters during a six minute walk test will be recorded.
Time Frame
At baseline, 12 and 24 weeks.
Title
Objectively measure of physical activity levels.
Description
Patients will wear an accelerometer for 7 full days.
Time Frame
At baseline, 12 and 24 weeks.
Title
Perceived physical activity levels.
Description
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.
Time Frame
At baseline, 12 and 24 weeks.
Title
Cancer-related fatigue by questionnaire.
Description
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.
Time Frame
At baseline, 12 and 24 weeks.
Title
Quality of life will be measured using a questionnaire.
Description
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.
Time Frame
At baseline, 12 and 24 weeks.
Title
Quality of life will be measured using questionnaires.
Description
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).
Time Frame
At baseline, 12 and 24 weeks.
Title
Pain will be measured through a questionnaire.
Description
Bone pain will be monitored using the Brief Pain Inventory Short Form (BPI-SF).
Time Frame
At baseline, 12 and 24 weeks.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Northern Ireland Cancer Centre, Belfast City Hospital
City
Belfast
ZIP/Postal Code
BT9 7JL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suneil Jain, PhD
Phone
44289097
Ext
2180
Email
s.jain@qub.ac.uk
First Name & Middle Initial & Last Name & Degree
Malcolm Brown, PhD
Phone
44289097
Ext
2434
Email
m.brown@qub.ac.uk

12. IPD Sharing Statement

Citations:
PubMed Identifier
31428443
Citation
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.
Results Reference
derived

Learn more about this trial

Exercise for Advanced Prostate Cancer: a Multicomponent Feasibility Trial

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