EXercise Enhancement After RadioTherapy for Bone Metastases

NCT ID: NCT06470503

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-13
• Study Completion Date: 2027-08-01

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.

Conditions

Bone Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

Exercise Program

8-week program and four-week short maintenance period.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18 or older.
• KPS ≥70

Exclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

24-5379

Identifier Type: -

Identifier Source: org_study_id