Supervised Exercise for Bone Cancer

Recruiting at 1 trial location

Overseen By Valerae O. Lewis, BS,MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cognitive disorder, Neurological disorder, others

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

Compensation: Varies

Number of Visits: 12

Duration: 4 weeks

45 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies how well supervised exercise works in improving physical fitness before surgery in patients with bone cancer that can be removed by surgery. Supervised exercise may provide better short-term physical fitness in patients with bone cancer.

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 Supervised Exercise for Bone Cancer?

Research shows that exercise can improve physical function and quality of life for people with bone metastases (cancer that has spread to the bones). It is considered a safe and effective way to help maintain independence and well-being in these patients. ^{1 2 3 4 5}

Is supervised exercise safe for people with bone cancer?

Research shows that supervised exercise can be safe for people with bone metastases (cancer spread to bones), though there are concerns about bone fractures. Studies suggest exercise may help improve physical function and quality of life, but it's important to follow a program designed by healthcare professionals to minimize risks. ^{1 2 6 7 8}

How does supervised exercise differ from other treatments for bone cancer?

Supervised exercise is unique because it focuses on improving physical function and quality of life for individuals with bone cancer, while also potentially suppressing tumor growth through biochemical changes in the body. Unlike traditional treatments, it is a non-invasive approach that can be tailored to individual needs, although it requires careful supervision to ensure safety due to concerns about bone fragility. ^{1 2 7 9 10}

Research Team

Valerae O. Lewis

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients newly diagnosed with primary bone tumors who are planning to have surgery and will receive at least 4 weeks of chemotherapy before the operation. They must be willing to wear a Fitbit and get their main cancer treatment at MD Anderson Cancer Center. Those with neurological or structural issues that prevent safe exercise, severe co-morbid illnesses, or cognitive disorders affecting safety adherence cannot join.

Inclusion Criteria

I am willing to wear a Fitbit.

I have been newly diagnosed with a bone tumor and will undergo surgery.

I will get chemotherapy for at least 4 weeks before my surgery.

Exclusion Criteria

Patients who have a cognitive disorder which impacts the ability to follow directions or adhere to safety rules; this will be determined by the physical therapist by assessing whether a neurological disorder or musculoskeletal disorder would prevent the patient from safely exercising

Any patient who, in the opinion of the investigators, will be unable to comply with a supervised exercise regimen

Any concurrent co-morbid illness and/or infection which in the opinion of the investigators could make the patient unable to comply fully with the trial procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo supervised physical therapy exercise sessions over 40 minutes 3-5 times a week for at least 4 weeks

4 weeks

12-20 sessions (in-person)

Follow-up

Participants are monitored for changes in tumor vascularity and other biomarkers

4 weeks

Treatment Details

Interventions

• Supervised Exercise

Trial Overview The study is testing whether supervised exercise can improve physical fitness in bone cancer patients before they undergo surgery. Participants will engage in an exercise regimen while wearing an activity monitor (Fitbit) to track their progress.

Participant Groups

Group I: Group II (fitbit) Experimental Treatment 1 Intervention

Patients wear a fitbit.

Group II: Group I (supervised exercise) Experimental Treatment 1 Intervention

Patients wear a fitbit and undergo supervised physical therapy exercise sessions over 40 minutes 3-5 times a week for at least 4 weeks.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A systematic review of 26 trials involving cancer survivors showed that various forms of exercise (aerobic, resistance, and mixed-mode) significantly improve bone mineral density (BMD) outcomes, particularly in the whole body, hip, and femoral neck.

The study supports the recommendation of exercise as an effective intervention for preventing bone loss in cancer survivors, with most trials being supervised and lasting from 12 weeks to 2 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of exercise for improving bone health in cancer survivors - A systematic review and meta-analysis. Singh, B., Toohey, K.[2021]

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]

References

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

Associations Among Physical Activity, Skeletal Related Events, and Patient Reported Outcomes in Patients with Bone Metastases. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

The effects of exercise on the bone health of people with cancer: a systematic review and meta-analysis. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

The effect of exercise for improving bone health in cancer survivors - A systematic review and meta-analysis. [2021]

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

Functional benefits are sustained after a program of supervised resistance exercise in cancer patients with bone metastases: longitudinal results of a pilot study. [2022]

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

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

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

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of a randomized controlled exercise trial on bone outcomes: influence of adjuvant endocrine therapy. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Can exercise suppress tumour growth in advanced prostate cancer patients with sclerotic bone metastases? A randomised, controlled study protocol examining feasibility, safety and efficacy. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Spinal Stabilization Exercises for Cancer Patients with Spinal Metastases of High Fracture Risk: Feasibility of the DISPO-II Training Program. [2021]