EXercise Enhancement After RadioTherapy for Bone Metastases

NCT06470503 | Enrolling By Invitation

• 1 other identifier: 24-5379
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Bone Metastases

Outcome Measures

Primary Outcomes (9)

• Incidence of toxicities as measured by CTCAE

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

  Up to 24 weeks

• Incidence of skeletal related events (SRE)

  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

  Up to 24 weeks

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

  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.

  Up to 24 weeks

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

  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.

  Up to 24 weeks

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

  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.

  Up to 24 weeks

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

  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.

  Up to 24 weeks

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

  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.

  Up to 24 weeks

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

  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.

  Up to 24 weeks

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

  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.

  Up to 24 weeks

Interventions

Exercise Program BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older.
• KPS ≥70

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 24, 2024
• Study Start: January 13, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CA (1)