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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a therapy using gentle vibrations to stop or reverse bone loss and boost immune cells in people with blood cancers. It targets individuals planning to undergo or who have recently undergone a bone marrow transplant or similar treatments. Known as Low-Intensity Mechanical Stimulation (or Vibration Therapy), this therapy may also strengthen muscles and stimulate T-cells, which are crucial for fighting diseases. It suits patients with specific blood cancers, such as non-Hodgkin lymphoma, and those eligible for certain transplants. As an unphased trial, this study offers a unique opportunity to explore innovative therapies that could enhance recovery and improve quality of life.

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 prior data suggests that this vibration therapy is safe for blood cancer patients?

Research has shown that low-intensity mechanical stimulation (LIMS) is generally safe. Studies have identified whole-body vibration, a type of LIMS, as a safe and helpful additional treatment for conditions like osteoporosis, which weakens bones. One study found that low-intensity vibration helped protect bone health in conditions like Duchenne Muscular Dystrophy, a disease that weakens muscles, indicating it is well-tolerated.

In children who have survived cancer and face bone density issues, low-magnitude, high-frequency mechanical stimulation proved to be a safe and promising option. This suggests that LIMS therapy might be safe and beneficial for individuals with bone concerns, including those with blood cancers.

While these findings are encouraging, they are based on previous studies and related conditions. Prospective clinical trial participants should discuss any concerns with healthcare professionals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Low-Intensity Mechanical Stimulation (LIMS) therapy for bone density loss because it offers a non-invasive and drug-free alternative to current treatments like bisphosphonates or hormone therapy. Unlike these medications, which can have significant side effects and require long-term use, LIMS uses gentle vibrations to stimulate bone growth, potentially reducing the risk of fractures without the need for pharmaceuticals. This method is unique in that it can be easily administered in short, 10-minute sessions, making it convenient and accessible for patients. Additionally, LIMS therapy could provide a safer option for patients who cannot tolerate traditional medications due to other health conditions.

What evidence suggests that low-intensity mechanical stimulation is effective for bone density loss in blood cancer patients?

Research shows that low-intensity mechanical stimulation (LIMS) vibration therapy might improve bone health. Studies have found that similar vibration treatments increased bone mineral density (BMD) in postmenopausal women and childhood cancer survivors. For these groups, the therapy also lowered the risk of fractures. In children who survived cancer, LIMS emerged as a new and safe way to strengthen bones. This trial will evaluate LIMS vibration therapy in two separate cohorts. Cohort I will undergo LIMS vibration therapy with follow-up DEXA scans, while Cohort II will receive LIMS vibration therapy twice daily for 14 days. LIMS might also aid in developing T-cells, which are important for the immune system, in patients receiving blood and bone marrow transplants. Overall, these findings suggest that LIMS could potentially improve bone strength and immune function in blood cancer patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Megan Herr, MD

Principal Investigator

Roswell Park Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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.

I am eligible for my first bone marrow transplant.

I am scheduled for a stem cell transplant using my own or a donor's cells.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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-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) 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-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]

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 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 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]

Citations

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Impact of low-magnitude, high frequency mechanical ... To evaluate the ability of low magnitude, high frequency mechanical stimulation to enhance bone mineral density among childhood cancer survivors.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0965229922000139

Systematic review and meta-analyses on the effects of ... Postmenopausal women experienced significant increase in bone mineral density following whole-body vibration treatment. •. Whole-body vibration reduced fracture ...

3. mdpi.com mdpi.com/2571-631X/6/2/28

Vibration Therapy for Cancer-Related Bone Diseases In this review, we will summarize the most cutting-edge vibration studies of cancer models and bone-cancer cell interactions.

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2499778

Effect of Low-Magnitude, High-Frequency Mechanical ... Pediatric cancer survivors with low BMD may benefit from low-magnitude, high-frequency mechanical stimulation as a novel and safe intervention to optimize peak ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-03605

Low-Intensity Mechanical Stimulation for Hematologic ... 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9664527/

Low‐Intensity Vibration Protects the Weight‐Bearing ... The ability of low‐intensity vibration (LIV) to combat skeletal decline in Duchenne Muscular Dystrophy (DMD) was evaluated in a randomized controlled trial.

7. effectivehealthcare.ahrq.gov effectivehealthcare.ahrq.gov/sites/default/files/pdf/osteoporosis-vibration-therapy_technical-brief.pdf

Whole-Body Vibration Therapy for Osteoporosis Manufacturers marketing low-intensity whole-body vibration platforms for treatment of osteoporosis or improvement of bone mineral density (BMD) specify through.