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EXercise Enhancement After RadioTherapy for Bone Metastases (EXERT-BM)

University Health Network, Toronto logo

University Health Network, Toronto

Status

Invitation-only

Conditions

Bone Metastases

Treatments

Behavioral: Exercise Program

Study type

Interventional

Funder types

Other

Identifiers

NCT06470503
24-5379

Details and patient eligibility

About

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).

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Michael Yan, MD, PhD

Data sourced from clinicaltrials.gov

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