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Trial Title:
EXercise Enhancement After RadioTherapy for Bone Metastases
NCT ID:
NCT06470503
Condition:
Bone Metastases
Conditions: Official terms:
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise Program
Description:
8-week program and four-week short maintenance period.
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).
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 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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 1, 2024
Completion date:
August 1, 2027
Lead sponsor:
Agency:
University Health Network, Toronto
Agency class:
Other
Source:
University Health Network, Toronto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06470503
