Low-Intensity Mechanical Stimulation for the Prevention of Bone Mineral Density Loss in Patients Undergoing Hematopoietic Cell Transplantation

Study Overview
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Brief Summary
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This clinical trial tests the effect of low-intensity mechanical stimulation (LIMS) vibration therapy on bone mineral density (BMD) in patients undergoing a blood and/or bone marrow transplant (hematopoietic cell transplantation [HCT]). HCT is a curative treatment for many blood cancers and as a consequence, there are more survivors with long-term effects such as loss of BMD. BMD loss can lead to increased risk of fractures and joint replacements. The LIMS board delivers vibrations through the bones that may stimulate bone growth and may also increase muscle activity and strength and as a result may improve BMD. LIMS vibration therapy may stop or reverse BMD loss in patients undergoing HCT

Detailed Description
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PRIMARY OBJECTIVE: I. Determine the feasibility of delivering a low-intensity mechanical stimulation (LIMS) program immediately following hematopoietic cell transplantation (HCT). SECONDARY OBJECTIVE: I. Determine the effect size of a LIMS program on bone marrow density (BMD) post-HCT. OUTLINE: Patients undergo LIMS vibration therapy on study. Patients also undergo dual x-ray absorptiometry (DEXA) scan at baseline and follow up and may optionally undergo blood sample collection and patient questionnaire at baseline and follow up.

Official Title
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Low-Intensity Mechanical Stimulation to Prevent Hematopoietic Cell Transplant-Related Bone Mineral Density Loss

Conditions
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Hematopoietic and Lymphoid System Neoplasm

Intervention / Treatment
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* Procedure: Low Intensity Vibration Therapy
* Procedure: Dual X-ray Absorptiometry
* Procedure: Biospecimen Collection
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet eligibility criteria for first autologous or allogeneic HCT (patients with preexisting osteoporosis are eligible) Scheduled to undergo an autologous or allogeneic HCT >= 18 years of age 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 Exclusion Criteria: Any prior allogeneic HCT Any prior autologous HCT for those patients who have a planned auto HCT Pre-transplant weight >= 275 lbs. (max weight for the board) Body mass index (BMI) < 18 kg/m^2 Recipient of cord blood transplant Multiple myeloma or amyloidosis diagnosis History of a central nervous system (CNS) hemorrhage < 60 days History of any aneurysm (cerebral, aortic, etc.) Currently treated with a therapeutic dose of anti-coagulation for a recent pulmonary embolism or deep vein thrombosis A cardiac pacemaker Prior history of non-traumatic (spontaneous) fracture Total joint replacement (any joint) History of kidney stones or gall stones within the last 2 years unless a cholecystectomy was performed Any prosthetic lower extremity or limb Pregnant or nursing female patients Unwilling or unable to follow protocol requirements Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study intervention

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIMS vibration Therapy<br>Patients undergo LIMS vibration therapy on study. Patients also undergo DEXA scan at follow up and may optionally undergo blood sample collection and questionnaire at baseline and follow up | Procedure: Low Intensity Vibration Therapy<br>* Undergo LIMS vibration therapy<br>* Other names: Low Intensity Virbration;Procedure: Dual X-ray Absorptiometry<br>* Undergo DEXA scan<br>* Other names: DEXA;Procedure: Biospecimen Collection<br>* Undergo blood sample collection<br>Other: Survey Administration<br>* Complete Survey<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time spent on LIMS | Will assess how much time and days use throughout study period | Up to 120 days post hematopoietic cell transplantation (HCT) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lumbar spine bone mineral density (BMD) | dual x-ray absorptiometry (DEXA) scans conducted as standard of care. BMD pre-HCT and post-HCT of patients who received LIMS compared to those who did not. A Linear regression used to compare the changes. | Up to 120 days post - HCT | 
| Change in femur BMD | Assessed using DEXA scans conducted as standard of care. BMD pre-HCT and post-HCT of patients who received LIMS will be compared to those who did not. A linear regression used to compare the changes. | UP to 120 days post - HCT | 
| Barriers to LIMS | Reasons why LIMS was not used | Up to 120 post -HCT | 
| Change in patient reported outcomes | Short form 36 will be used to assess physical activities - comprising of 36 questions with ranges from 0 (worst) to 100 (Best) | Pre HCT and at time of second DEXA: day +80 |