Clinical trial NCT06470503: EXercise Enhancement After RadioTherapy for Bone Metastases
Official title: EXercise Enhancement After RadioTherapy for Bone Metastases - A Phase I Feasibility Trial for Patients With Painful Non-Spine Bone Metastases
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Bone Metastases
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: Incidence of toxicities as measured by CTCAE
timeFrame: Up to 24 weeks
measure: Incidence of skeletal related events (SRE)
timeFrame: Up to 24 weeks
measure: Change in pain response at index lesion(s) based Numeric Pain Rating Scale (NPRS)
timeFrame: Up to 24 weeks
measure: Health-related quality-of-life and as measured by the EORTC QLQ C30
timeFrame: Up to 24 weeks
measure: Health-related quality-of-life and as measured by the BM22
timeFrame: Up to 24 weeks
measure: Change in functional outcomes as measured by 30s sit to stand (STS).
timeFrame: Up to 24 weeks
measure: Change in functional outcomes as measured by time up and go (TUG) tests.
timeFrame: Up to 24 weeks
measure: Change in functional outcomes as measured by 6-minute walk test (6MWT)
timeFrame: Up to 24 weeks
measure: Self-assessment of physical activity as measured by the modified GODIN questionnaire
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References: