EXercise Enhancement After RadioTherapy for Bone Metastases (NCT06470503) | Clinical Trial Compass
By InvitationNot Applicable
EXercise Enhancement After RadioTherapy for Bone Metastases
Canada20 participantsStarted 2025-01-13
Plain-language summary
The purpose of this study is to evaluate the safety, feasibility, and acceptability of a structured, supervised exercise program combined with standard palliative radiotherapy for patients with painful non-spine bone metastases (NSBM).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 or older.
* KPS ≥70
* Histologically confirmed cancer and radiologically documented NSBM metastases. Spine metastases are allowed if they do not meet the exclusion criteria below.
* At least one painful NSBM treated with palliative radiotherapy.
* Independent with ambulation and transfers. Ambulatory aids are permitted.
* Life expectancy of at least 6 months
Exclusion Criteria:
* Any untreated metastatic disease that may preclude safely performing physical exercise including:
* History of leptomeningeal disease
* Active (untreated/progressive) malignant spinal cord or cauda equina compression
* Bilsky 2 or 3
* Neurological compromise secondary to CNS involvement
* Symptomatic brain metastases prohibiting exercise due to neurological compromise
* High risk of instability of any boney lesion(s) that may require orthopedic intervention
* SINS score \> 7
* Mirels score \> 6
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of toxicities as measured by CTCAE
Timeframe: Up to 24 weeks
2
Incidence of skeletal related events (SRE)
Timeframe: Up to 24 weeks
3
Change in pain response at index lesion(s) based Numeric Pain Rating Scale (NPRS)
Timeframe: Up to 24 weeks
4
Health-related quality-of-life and as measured by the EORTC QLQ C30
Timeframe: Up to 24 weeks
5
Health-related quality-of-life and as measured by the BM22
Timeframe: Up to 24 weeks
6
Change in functional outcomes as measured by 30s sit to stand (STS).
Timeframe: Up to 24 weeks
7
Change in functional outcomes as measured by time up and go (TUG) tests.