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Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

ConditionHematopoietic and Lymphoid System Neoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoswell Park Cancer Institute

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

COHORT I: Meet eligibility criteria for first autologous or allogeneic HCT (patients with preexisting osteoporosis are eligible)

COHORT I: Scheduled to undergo an autologous or allogeneic HCT

COHORT 1: >= 18 years of age

COHORT 1: 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

Disqualifiers

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/m²

Trial design

Design model

Single group

Treatments tested in this trial

  • Low Intensity Vibration Therapy

    Procedure/Surgery

    Undergo LIMS vibration therapy

  • Dual X-ray Absorptiometry

    Procedure/Surgery

    Undergo DEXA scan

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: LIMS vibration Therapy, DEXA Scan - Cohort 1Experimental treatment 3 interventions
Group B: LIMS vibration therapy - Cohort IIExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

time spent on LIMS - Cohort I

Will assess how much time and days use throughout study period

Time frame
Up to 120 days post hematopoietic cell transplantation (HCT)
2

Chimeric antigen receptor (CAR) T-cell product efficacy - Cohort II

Blood samples will be collected for CAR-T cell efficacy before and after LIMS sessions

Time frame
up to 120 days post hematopoietic cell transplantation

Secondary outcomes

1

Change in lumbar spine bone mineral density (BMD) - Cohort 1

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.

Time frame
Up to 120 days post - HCT
2

Change in femur BMD - Cohort 1

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.

Time frame
UP to 120 days post - HCT
3

Barriers to LIMS- Cohort 1

Reasons why LIMS was not used

Time frame
Up to 120 post -HCT
4

Change in patient reported outcomes - Cohort 1

Short form 36 will be used to assess physical activities - comprising of 36 questions with ranges from 0 (worst) to 100 (Best)

Time frame
Pre HCT and at time of second DEXA: day +80

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Roswell Park Cancer Institute

Lead sponsor

Source ClinicalTrials.gov
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