EXercise Enhancement After RadioTherapy for Bone Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise Program.
- Who it may be relevant to
- Registry conditions: Bone Metastases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
EXercise Enhancement After RadioTherapy for Bone Metastases - A Phase I Feasibility Trial for Patients With Painful Non-Spine Bone Metastases
Overview
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).
Detailed description
This study investigates the potential benefits of exercise therapy for patients with bone metastases, a common and often painful complication of cancer. The study aims to determine whether a structured exercise program, in combination with standard of care cancer treatment, can improve physical function, quality of life, and overall well-being for patients undergoing palliative radiotherapy.
Participants will complete a 8-week supervised exercise program delivered virtually through CARE@Home-AC, that is tailored to their individual needs and abilities. The exercises, guided by certified professionals, will focus on improving strength, flexibility, and mobility. Participants will also receive educational sessions covering various aspects of self-management and coping strategies.
The study monitor the safety and feasibility of the exercise program, as well as its impact on pain levels, functional abilities, and quality of life. Follow-up assessments will occur at 1, 3, and 6 months post-intervention to track progress and gather valuable insights into the potential benefits of exercise therapy for individuals with bone metastases.
By exploring the role of exercise in cancer care, this study seeks to empower patients with new tools to manage their symptoms, enhance their well-being, and improve their overall quality of life throughout their cancer journey.
Interventions
- Behavioral Exercise Program
8-week program and four-week short maintenance period.
Primary outcome measures
- Incidence of toxicities as measured by CTCAE [Time frame: Up to 24 weeks]
- Incidence of skeletal related events (SRE) [Time frame: Up to 24 weeks]
- Change in pain response at index lesion(s) based Numeric Pain Rating Scale (NPRS) [Time frame: Up to 24 weeks]
- Health-related quality-of-life and as measured by the EORTC QLQ C30 [Time frame: Up to 24 weeks]
- Health-related quality-of-life and as measured by the BM22 [Time frame: Up to 24 weeks]
- Change in functional outcomes as measured by 30s sit to stand (STS). [Time frame: Up to 24 weeks]
- Change in functional outcomes as measured by time up and go (TUG) tests. [Time frame: Up to 24 weeks]
- Change in functional outcomes as measured by 6-minute walk test (6MWT) [Time frame: Up to 24 weeks]
- Self-assessment of physical activity as measured by the modified GODIN questionnaire [Time frame: Up to 24 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Canada · 1 center
- Princess Margaret Cancer Centre — Toronto
Identifiers
NCT: NCT06470503 · 24-5379