Clinical trial NCT03658486: Exercise for Advanced Prostate Cancer: a Multicomponent Feasibility Trial
Official title: Exercise for Advanced Prostate Cancer: a Multicomponent Feasibility Trial in Men With Metastatic Castrate-Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer Metastatic
Castration-resistant Prostate Cancer
Keywords: Exercise
Metastatic castrate-resistant prostate cancer
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: HSC Public Health Agency
First posted: 2018-09-05
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Feasibility - recruitment.
timeFrame: At baseline.
measure: Feasibility - adherence to the exercise intervention.
timeFrame: Throughout the 24 week study period.
measure: Feasibility - attrition rates.
timeFrame: Throughout the 24 week study period.
measure: Feasibility - safety / adverse events.
timeFrame: Monitored throughout the 24 week study period.
measure: Feasibility - patient experience.
timeFrame: Following the study conclusion at 24 weeks.
Secondary outcomes:
measure: Anthropometric assessment.
timeFrame: At baseline, 12 and 24 weeks.
measure: Hip and waist circumference analysis.
timeFrame: At baseline, 12 and 24 weeks.
measure: Functional ability assessment.
timeFrame: At baseline, 12 and 24 weeks.
measure: Physical fitness assessment.
timeFrame: At baseline, 12 and 24 weeks.
measure: Objectively measure of physical activity levels.
timeFrame: At baseline, 12 and 24 weeks.
measure: Perceived physical activity levels.
timeFrame: At baseline, 12 and 24 weeks.
measure: Cancer-related fatigue by questionnaire.
timeFrame: At baseline, 12 and 24 weeks.
measure: Quality of life will be measured using a questionnaire.
timeFrame: At baseline, 12 and 24 weeks.
measure: Quality of life will be measured using questionnaires.
timeFrame: At baseline, 12 and 24 weeks.
measure: Pain will be measured through a questionnaire.
timeFrame: At baseline, 12 and 24 weeks.
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Northern Ireland Cancer Centre, Belfast City Hospital
Study officials:
References:
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.