Exercise Program for Bone Metastases

(EXERT-BM Trial)

Overseen By Michael Yan, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Leptomeningeal disease, Spinal cord compression, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Structured Exercise Program for bone metastases?

Research shows that exercise can improve physical function and quality of life for people with bone metastases. A case study of a patient with metastatic bone disease found that an aerobic exercise program improved her physical performance and quality of life. Additionally, a systematic review and expert consensus highlight the potential benefits and safety of exercise for individuals with bone metastases. ^{1 2 3 4 5}

Is exercise safe for people with bone metastases?

Research shows that exercise can be safe for people with bone metastases, but it is often avoided due to concerns about bone fractures. Studies have examined the safety of exercise programs, and while they show potential benefits, they emphasize the need for careful supervision to prevent injury. ^{1 2 4 6 7}

How is the exercise program treatment for bone metastases different from other treatments?

This exercise program is unique because it focuses on improving physical function and quality of life in patients with bone metastases, which is often avoided due to safety concerns. Unlike traditional treatments that may focus on medication or surgery, this program uses a modular multi-modal approach to safely incorporate exercise, addressing muscle atrophy and functional impairments. ^{1 2 3 4 8}

Eligibility Criteria

This trial is for adults with confirmed cancer and non-spine bone metastases that cause pain. They must be over 18 years old, have a Karnofsky Performance Status (KPS) of 70 or above, indicating they can care for themselves with some assistance.

Inclusion Criteria

My cancer has spread to my brain or spine, confirmed by tests.

Life expectancy of at least 6 months

I can walk and move around on my own, but I may use a walking aid.

Exclusion Criteria

SINS score > 7

I have had cancer spread to the lining of my brain and spinal cord.

Mirels score > 6

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Participants receive standard palliative radiotherapy for bone metastases

1-2 weeks

Exercise Program

Participants complete an 8-week supervised exercise program tailored to their needs, focusing on strength, flexibility, and mobility

8 weeks

Regular supervised sessions

Follow-up

Participants are monitored for safety and effectiveness after the exercise program, with assessments at 1, 3, and 6 months post-intervention

6 months

3 follow-up assessments

Treatment Details

Interventions

• Structured Exercise Program

Trial Overview The study is testing the combination of a structured exercise program with standard palliative radiotherapy to see if it's safe and helpful for patients suffering from painful bone metastases not located in the spine.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

A study involving 57 prostate cancer patients with bone metastases showed that a multimodal exercise program significantly improved self-reported physical functioning and lower body muscle strength after 3 months, compared to usual care.

The exercise program was safe, with no reported exercise-related adverse events or skeletal fractures, indicating that supervised exercise can be beneficial for patients with bone metastases without increasing the risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Preserves Physical Function in Prostate Cancer Patients with Bone Metastases. Galvão, DA., Taaffe, DR., Spry, N., et al.[2022]

A 48-year-old woman with advanced breast cancer showed significant improvements in her physical fitness, with VO2max increasing by 52.7% after 12 months of a structured aerobic exercise program.

The exercise program, which involved cycling three times a week, not only enhanced her peak work capacity by 35.7% but also led to a notable improvement in her overall quality of life, suggesting that aerobic exercise can be a beneficial palliative treatment for cancer patients with bone metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise for a patient suffering from metastatic bone disease. Crevenna, R., Schmidinger, M., Keilani, M., et al.[2004]

This study aims to evaluate the safety and efficacy of a 3-month modular multi-modal exercise program for 90 prostate cancer survivors with bone metastases, addressing concerns about muscle atrophy and functional impairments due to prior treatments.

The exercise program is designed to be safe for patients with bone metastases, potentially improving physical function and delaying skeletal complications, which could significantly enhance the quality of life for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial. Galvão, DA., Taaffe, DR., Cormie, P., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility of isometric spinal muscle training in patients with bone metastases under radiation therapy - first results of a randomized pilot trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Exercise Preserves Physical Function in Prostate Cancer Patients with Bone Metastases. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Exercise Recommendation for People With Bone Metastases: Expert Consensus for Health Care Providers and Exercise Professionals. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise for individuals with bone metastases: A systematic review. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Aerobic exercise for a patient suffering from metastatic bone disease. [2004]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Effects of Football in Skeletal Metastatic Prostate Cancer: a Subgroup Analysis of the FC Prostate Community Randomised Controlled Trial. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise and Bone Health in Cancer: Enemy or Ally? [2022]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a modular multi-modal exercise program in prostate cancer patients with bone metastases: a randomized controlled trial. [2022]