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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a supervised exercise program can safely assist individuals with painful bone cancer that has spread beyond the spine. Participants will engage in this exercise program alongside their usual radiation treatment to determine if it improves comfort and mobility. Ideal candidates can walk independently and have bone cancer causing pain, already managed with radiation. As an unphased trial, this study allows participants to contribute to innovative research that could enhance the quality of life for others with similar conditions.

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 prior data suggests that this exercise program is safe for patients with bone metastases?

Research has shown that exercise programs are generally safe for people with cancer that has spread to their bones. One study found very few serious side effects linked to exercise, with none related to bone problems. Another survey revealed that 82% of participants agreed exercise is safe for those with bone metastases.

Further findings indicate that supervised exercise can help reduce tiredness, pain, and breathing issues. Overall, these studies suggest that exercise is well-tolerated and beneficial for people dealing with bone metastases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the structured exercise program for bone metastases because it offers a non-invasive approach to managing this condition. Unlike traditional treatments like medication or radiation, which can have significant side effects, exercise aims to improve bone strength and overall physical function. This approach could provide patients with a way to manage their symptoms and enhance their quality of life without the drawbacks of more conventional therapies. By focusing on physical activity, this program may also help in maintaining patients' independence and well-being during their cancer journey.

What evidence suggests that this exercise program is effective for bone metastases?

Studies have shown that planned exercise routines can be safe and may enhance movement and independence in patients with cancer that has spread to the bones. Research indicates that supervised exercise can reduce fatigue and improve the quality of life for patients with metastatic breast cancer (MBC). Most experts agree that exercise is safe for individuals with bone metastases. Very few serious problems were linked to exercise, and none were due to the cancer in the bones. Overall, while results vary, planned exercise is generally considered beneficial for those with bone metastases. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12523373/

Movement-Based Interventions in Patients Affected by ...

Conclusions: Structured physical activity appears safe and may improve function and independence in patients with bone metastases. These ...

2.

nature.com

nature.com/articles/s41591-024-03143-y

Supervised, structured and individualized exercise in ...

These results demonstrate that supervised exercise has positive effects on physical fatigue and HRQOL in patients with MBC and should be recommended as part of ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/OP.21.00454

Exercise Recommendation for People With Bone Metastases

In the survey, most respondents agreed that exercise for people with bone metastases was safe (82%) and these individuals look to their health ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1040842821002213

Exercise for individuals with bone metastases: A systematic ...

Few (n = 4, 0.5%) serious adverse events were attributed to exercise participation, with none related to bone metastases. Mixed efficacy results ...

5.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/22104917241286062

The efficacy and safety of exercise in patients with bone ...

Guided training appeared safe in early-stage palliative cancer cases with bone metastasis. No significant change in physical function and quality of life was ...