Low-Intensity Vibration Therapy for Bone Density Loss in Blood Cancer Patients

Overseen By Megan Herr, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Prior HCT, BMI < 18, Aneurysm, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 180 days

75 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial tests the effect of low-intensity mechanical stimulation (LIMS) vibration therapy in patients with hematologic malignancies. Patients with hematologic malignancies often undergo a blood and/or bone marrow transplant (hematopoietic cell transplantation \[HCT\]) or cellular therapy. The LIMS board delivers vibrations through the bones that may stimulate bone growth and may also increase muscle activity and strength and may also increase T-cell activation in patients planning to undergo cellular therapy. LIMS vibration therapy may stop or reverse BMD loss and/or improve the development of T-cells in the body in patients with hematologic malignancies who are undergoing or may plan to undergo HCT or cellular therapies.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of Low-Intensity Vibration Therapy for Bone Density Loss in Blood Cancer Patients?

Research shows that low-intensity vibration therapy can improve bone strength and quality in postmenopausal women and children with cerebral palsy, suggesting it may help prevent bone loss in other conditions too. This therapy works by stimulating bone cells and improving bone density without the use of drugs. ^{1 2 3 4 5}

Is Low-Intensity Vibration Therapy safe for humans?

Low-Intensity Vibration Therapy has been studied in humans and animals, showing potential benefits for bone health without significant safety concerns when used at low intensities. However, caution is advised with higher intensities, as they may pose risks to various body systems. ^{2 3 6 7 8}

How does low-intensity vibration therapy differ from other treatments for bone density loss in blood cancer patients?

Low-intensity vibration therapy is unique because it uses mechanical signals to stimulate bone growth and prevent bone loss without the use of drugs. This non-drug approach is particularly beneficial as it avoids potential side effects associated with medications and can be safely used alongside cancer treatments without promoting cancer progression. ^{1 2 3 4 6}

Research Team

Megan Herr, MD

Principal Investigator

Roswell Park Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults over 18 who are about to have their first blood or bone marrow transplant for blood cancer treatment. It's open to those with osteoporosis and requires understanding and consent to study procedures. Exclusions include a weight over 275 lbs, BMI under 18, certain medical conditions like joint replacements, history of kidney or gall stones within two years (unless treated), pregnancy, recent fractures without trauma, pacemakers, specific diagnoses like multiple myeloma or amyloidosis, and current heavy anticoagulant use.

Inclusion Criteria

I have been diagnosed with a specific type of non-Hodgkin lymphoma.

COHORT II: Patient must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure

I am eligible for my first bone marrow transplant.

Exclusion Criteria

I am currently on a therapeutic dose of anti-coagulation for a recent clot in my lung or leg.

COHORT 1: Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study intervention

I have been diagnosed with multiple myeloma or amyloidosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo LIMS vibration therapy. Cohort 1: 10 minutes once daily from day -8 to -1 during admission for HCT and until day 180 at home. Cohort II: 10 minutes twice daily for 14 days.

Up to 180 days

Daily sessions, home-based

Follow-up

Participants undergo DEXA scans and may have blood samples collected to assess bone mineral density and CAR T-cell efficacy.

Up to 120 days post-HCT

DEXA scan and blood sample collection

Treatment Details

Interventions

• Low-Intensity Mechanical Stimulation

Trial Overview The trial examines if low-intensity mechanical stimulation (LIMS) vibration therapy can prevent loss of bone density in patients undergoing hematopoietic cell transplantation. LIMS involves standing on a board that sends vibrations through the bones which may stimulate growth and improve muscle strength potentially improving bone mineral density.

Participant Groups

Group I: LIMS vibration therapy - Cohort II Experimental Treatment 2 Interventions

Patients undergo LIMS vibration therapy over 10-minutes BID for 14 days on study. Patients also undergo blood sample collection throughout the trial.

Group II: LIMS vibration Therapy, DEXA Scan - Cohort 1 Experimental Treatment 3 Interventions

Patients undergo LIMS vibration therapy over 10 minutes on study. Patients also undergo DEXA scan at follow up and may optionally undergo blood sample collection and questionnaire at baseline and follow up

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Findings from Research

In a randomized double-blinded trial involving postmenopausal women, daily vibration therapy for 10 minutes over one year significantly improved bone stiffness and reduced marrow fat, suggesting it may help combat bone density loss.

The treatment group showed a 3.86% greater increase in tibial stiffness compared to the placebo group, along with significant improvements in trabecular bone volume and density, indicating that vibration therapy could be a nonpharmacological approach to enhance bone health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Low-Intensity Vibration on Bone Strength, Microstructure, and Adiposity in Pre-Osteoporotic Postmenopausal Women: A Randomized Placebo-Controlled Trial. Rajapakse, CS., Johncola, AJ., Batzdorf, AS., et al.[2022]

Low-intensity vibration (LIV) can effectively transmit mechanical signals through the axial skeleton of individuals with spinal cord injury (SCI), showing similar transmission rates to able-bodied controls across different tilt angles.

The study suggests that LIV could be a promising therapeutic intervention to help prevent or reverse bone loss in people with SCI, as it demonstrated effective signal transmission even in non-ambulatory subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transmission of low-intensity vibration through the axial skeleton of persons with spinal cord injury as a potential intervention for preservation of bone quantity and quality. Asselin, P., Spungen, AM., Muir, JW., et al.[2021]

Low intensity vibration (LIV) has been shown to improve bone quality by regulating the activity of bone remodeling cells and influencing stem cell differentiation, making it a promising non-drug treatment for osteoporosis.

While vibration can be beneficial, caution is necessary as chronic exposure to high-intensity vibrations can negatively affect physiological systems; thus, LIV offers a safer alternative for enhancing musculoskeletal health, especially in the elderly and those with injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The potential benefits and inherent risks of vibration as a non-drug therapy for the prevention and treatment of osteoporosis. Chan, ME., Uzer, G., Rubin, CT.[2022]

Low intensity vibration (LIV) treatment in mice prone to cancer significantly increased bone mass by 25% in the tibiae and 16% in the vertebrae after one year, indicating its efficacy in preserving bone density during cancer progression.

LIV did not negatively impact survival rates and may even reduce tumor incidence by approximately 30%, suggesting that mechanical signals can help manage bone health without promoting cancer growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low magnitude mechanical signals mitigate osteopenia without compromising longevity in an aged murine model of spontaneous granulosa cell ovarian cancer. Pagnotti, GM., Adler, BJ., Green, DE., et al.[2021]

Low magnitude, high frequency vibration (LMHFV) is emerging as a promising therapy for improving bone structure and muscle performance, particularly in conditions like osteoporosis that significantly affect quality of life.

Research is expanding on how LMHFV influences cellular responses in the musculoskeletal system, including its effects on bone-forming cells (osteogenesis) and fat-forming cells (adipogenesis), although the exact mechanisms of action remain poorly understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibration stimuli and the differentiation of musculoskeletal progenitor cells: Review of results in vitro and in vivo. Edwards, JH., Reilly, GC.[2020]

Low-intensity vibration (LIV) therapy, applied for 15 minutes twice daily over 35 days after spinal cord injury (SCI), improved biomarkers of bone turnover and gene expression in an animal model, suggesting potential benefits for bone health post-SCI.

LIV significantly reduced the osteoclastogenic potential of bone marrow precursors by 70%, indicating its effectiveness in counteracting bone loss mechanisms after SCI, although it did not change overall bone mineral density.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of low intensity vibration on bone and muscle in rats with spinal cord injury. Bramlett, HM., Dietrich, WD., Marcillo, A., et al.[2021]

Low magnitude, low frequency (LMLF) mechanical vibrations at 25 Hz significantly enhanced the proliferation and osteogenic differentiation of human adipose-derived mesenchymal stem cells from elderly patients over a 21-day period.

The study demonstrated that LMLF vibrations led to the formation of bone-like structures and increased calcium and phosphorus deposits, suggesting potential for improving cell-based therapies for bone deficits in older individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Low-Magnitude Low-Frequency Vibrations (LMLF) on Osteogenic Differentiation Potential of Human Adipose Derived Mesenchymal Stem Cells. Marędziak, M., Lewandowski, D., Tomaszewski, KA., et al.[2022]

Low-intensity vibration (LIV) treatment in mice with myeloma significantly protected against bone loss, showing only a 21% decrease in trabecular bone volume compared to a dramatic 86% loss in untreated mice, indicating its potential efficacy in preserving bone health during myeloma progression.

LIV also reduced tumor burden in the bone marrow by 31% and decreased the incidence of advanced-stage necrosis, suggesting that LIV not only helps maintain bone quality but also inhibits tumor progression in myeloma-affected mice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low intensity vibration mitigates tumor progression and protects bone quantity and quality in a murine model of myeloma. Pagnotti, GM., Chan, ME., Adler, BJ., et al.[2018]

References

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

Effect of Low-Intensity Vibration on Bone Strength, Microstructure, and Adiposity in Pre-Osteoporotic Postmenopausal Women: A Randomized Placebo-Controlled Trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Transmission of low-intensity vibration through the axial skeleton of persons with spinal cord injury as a potential intervention for preservation of bone quantity and quality. [2021]

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

The potential benefits and inherent risks of vibration as a non-drug therapy for the prevention and treatment of osteoporosis. [2022]

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

Low magnitude mechanical signals mitigate osteopenia without compromising longevity in an aged murine model of spontaneous granulosa cell ovarian cancer. [2021]

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

Vibration stimuli and the differentiation of musculoskeletal progenitor cells: Review of results in vitro and in vivo. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Effects of low intensity vibration on bone and muscle in rats with spinal cord injury. [2021]

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

The Effect of Low-Magnitude Low-Frequency Vibrations (LMLF) on Osteogenic Differentiation Potential of Human Adipose Derived Mesenchymal Stem Cells. [2022]

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

Low intensity vibration mitigates tumor progression and protects bone quantity and quality in a murine model of myeloma. [2018]