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Hematopoietic and Lymphoid System NeoplasmNCT05893940

Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

A study testing Low Intensity Vibration Therapy, Dual X-ray Absorptiometry and Biospecimen Collection in people with Hematopoietic and Lymphoid System Neoplasm, run by Roswell Park Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Low Intensity Vibration Therapy, Dual X-ray Absorptiometry and Biospecimen Collection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited States
Study dates
14 Aug 2023to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • COHORT II: ≥ 18 years of age
  • COHORT II: Diagnosis of non-Hodgkin lymphoma (specifically diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia; patients with preexisting osteoporosis are eligible)
  • 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

Who cannot join

  • COHORT 1:
  • 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
Show all 33Show fewer
  • Multiple myeloma or amyloidosis diagnosis
  • History of a central nervous system (CNS) hemorrhage < 60 days
  • History of any aneurysm (cerebral, aortic, etc.)
  • 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
  • COHORTII:
  • Planned CAR T-cell therapy within the next 2 months
  • Prior CAR T-cell therapy
  • Active treatment within the last 60 days
  • Pre-transplant weight ≥ 275 lbs. (max weight for the board)
  • BMI < 18 kg/m^2
  • History of a CNS hemorrhage < 60 days
  • History of any aneurysm (cerebral, aortic, etc.)
  • A recent pulmonary embolism or deep vein thrombosis
  • A cardiac pacemaker
  • Recent history (< 60 days) of non-traumatic (spontaneous) fracture
  • Recent surgery (< 60 days)
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Megan Herr, MD contact

716-845-3557

Megan.Herr@roswellpark.org

United States1 site, 1 recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

    Megan Herr, MD, 877-275-7724, askroswell@roswellpark.org

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. Determine the feasibility of delivering a low-intensity mechanical stimulation (LIMS) program immediately following hematopoietic cell transplantation (HCT). COHORT 1 II. II. Evaluate chimeric antigen receptors (CAR) T-cell product efficacy of Non-Hodgkin lymphoma (NHL) patients undergoing LIMS in comparison to patients not treated with LIMS. COHORT II

SECONDARY OBJECTIVE:

  1. Determine the effect size of a LIMS program on bone marrow density (BMD) post-HCT.

COHORT 1 II. Evaluate the manufacturing parameters (product viability, total cell dose, transduction efficiency, time to produce the CAR T-cell product) pre- and post-LIMS. COHORT II

OUTLINE:

Patients are assigned to 1 of 2 cohorts.

COHORT 1 - Patients undergo LIMS vibration therapy over 10-minutes once a day on study. Treatment begins day -8 to -1 during admission for HCT and until day 180 using the LIMS board at home. Patients also undergo dual x-ray absorptiometry (DEXA) scan at follow up and may optionally undergo blood sample collection at baseline and follow up.

COHORT II: Patients undergo LIMS vibration therapy over 10-minutes twice daily (BID) for 14 days on study. Patients also undergo blood sample collection throughout the trial

Being tested
Low Intensity Vibration Therapy, Dual X-ray Absorptiometry, Biospecimen Collection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Intensity Vibration TherapyProcedure or surgery

    Also called LIV, Low Intensity Virbration

    Undergo LIMS vibration therapy

  • Dual X-ray AbsorptiometryProcedure or surgery

    Also called BMD scan, bone mineral density scan, DEXA

    Undergo DEXA scan

  • Biospecimen CollectionProcedure or surgery

    Undergo blood sample collection

Study groups in NCT05893940
Study groupRoleWhat they receive
LIMS vibration Therapy, DEXA Scan - Cohort 1ExperimentalPatients 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
Receives: Procedure: Low Intensity Vibration Therapy; Procedure: Dual X-ray Absorptiometry; Procedure: Biospecimen Collection
LIMS vibration therapy - Cohort IIExperimentalPatients undergo LIMS vibration therapy over 10-minutes BID for 14 days on study. Patients also undergo blood sample collection throughout the trial.
Receives: Procedure: Low Intensity Vibration Therapy; Procedure: Biospecimen Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time spent on LIMS - Cohort I

    Will assess how much time and days use throughout study period

    Measured: 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

    Measured: up to 120 days post hematopoietic cell transplantation

Secondary outcomes (4)

  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.

    Measured: 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.

    Measured: UP to 120 days post - HCT

  3. Barriers to LIMS- Cohort 1

    Reasons why LIMS was not used

    Measured: 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2023
  2. Study start14 Aug 2023
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05893940
Sponsor's protocol ID
I-3434822
Status last verified
Aug 2026
First submitted
30 May 2023
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Low Intensity Vibration Therapy, Dual X-ray Absorptiometry and Biospecimen Collection in people with Hematopoietic and Lymphoid System Neoplasm, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Megan Herr, MD (716-845-3557, Megan.Herr@roswellpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time spent on LIMS - Cohort I (time frame: Up to 120 days post hematopoietic cell transplantation (HCT)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05893940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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