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Enrolling by Invitation

NCT Number: NCT06470503

EXercise Enhancement After RadioTherapy for Bone Metastases

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).

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Key information

Conditions

Bone Metastases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Program

Behavioral

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

Primary outcomes

  1. Incidence of toxicities as measured by CTCAE

    Time frame: Up to 24 weeks

    The severity of adverse events will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grading scale.

  2. Incidence of skeletal related events (SRE)

    Time frame: Up to 24 weeks

    An SRE is defined as any of the following of a target bone metastases: Pathological fracture, Spinal cord compression, Indication for orthopedic surgery, Indication for radiotherapy

  3. Change in pain response at index lesion(s) based Numeric Pain Rating Scale (NPRS)

    Time frame: Up to 24 weeks

    NPRS refers to a score of 0 to 10 on a visual analogue scale, with 0 referring to no pain and 10 referring to the worst pain imaginable.

  4. Health-related quality-of-life and as measured by the EORTC QLQ C30

    Time frame: Up to 24 weeks

    The C30 is a 30-item instrument that evaluates HRQOL comprised of five functional scales (physical, cognitive, emotional, social, and role) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, anorexia, constipation, diarrhea, and financial), and a global QoL scale.

  5. Health-related quality-of-life and as measured by the BM22

    Time frame: Up to 24 weeks

    The BM22 scale is specific to patients with bone metastases. It consists of four domains that evaluate pain characteristics, pain sites, functional interference, and psychosocial aspects relating to bone metastases.

  6. Change in functional outcomes as measured by 30s sit to stand (STS).

    Time frame: Up to 24 weeks

    The STS will assess how many repetitions from sitting to standing a patient can perform in 30 seconds without the use of their arms. Patients will sit in a standard chair (43.2cm off ground) placed against a wall for stability, with a straight back.

  7. Change in functional outcomes as measured by time up and go (TUG) tests.

    Time frame: Up to 24 weeks

    The TUG will start with a patient in the seated position. On "Go", they will stand up, walk at a comfortable pace to a pre-marked line 3m away from the chair, turn around, and return back to the chair to sit down again. The timer starts on "Go", and stops when the patient sits back down on the chair. Total exercise participation will be assessed by obtaining FitBit data pertaining to step count, heart rate, and sleep for participant leisure time and purposeful physical activity.

  8. Change in functional outcomes as measured by 6-minute walk test (6MWT)

    Time frame: Up to 24 weeks

    The 6MWT test will assess the maximal distance a patient can ambulate within the 6-minute time frame, often back and forth down a measured hallway. Walking aids are permissible.

  9. Self-assessment of physical activity as measured by the modified GODIN questionnaire

    Time frame: Up to 24 weeks

    Self-assessment of physical activity will be assessed at baseline and follow up using the modified GODIN leisure-time exercise questionnaire. This is a simple questionnaire that quantifies ≥15m episodes of strenuous, moderate, and light exercise in the past 7-day period from questionnaire administration. A summary score and interpretative scale is provided based on a calculated algorithm.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

EXercise Enhancement After RadioTherapy for Bone Metastases - A Phase I Feasibility Trial for Patients With Painful Non-Spine Bone Metastases

Acronym: EXERT-BM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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