EXercise Enhancement After RadioTherapy for Bone Metastases

Condition(s) studied

Investigational drug(s) / intervention(s)

Exercise Program: 8-week program and four-week short maintenance period.

Study 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).

Eligibility

Primary outcome measure(s)

• Incidence of toxicities as measured by CTCAE — 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.
• Incidence of skeletal related events (SRE) — 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
• Change in pain response at index lesion(s) based Numeric Pain Rating Scale (NPRS) — 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.
• Health-related quality-of-life and as measured by the EORTC QLQ C30 — 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.
• Health-related quality-of-life and as measured by the BM22 — 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.
• Change in functional outcomes as measured by 30s sit to stand (STS). — 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.
• Change in functional outcomes as measured by time up and go (TUG) tests. — 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.
• Change in functional outcomes as measured by 6-minute walk test (6MWT) — 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.
• Self-assessment of physical activity as measured by the modified GODIN questionnaire — 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.

Trial sites (1)

More University Health Network, Toronto trials in Canada