Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

Last updated: December 2, 2025
Sponsor: Roswell Park Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hematologic Neoplasms

Treatment

Dual X-ray Absorptiometry

Survey Administration

Biospecimen Collection

Clinical Study ID

NCT05893940
I-3434822
  • Ages > 18
  • All Genders

Study 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. 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

Inclusion

Inclusion Criteria:

  • COHORT I: Meet eligibility criteria for first autologous or allogeneic HCT (patientswith 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 signan institutional review board approved written informed consent form prior toreceiving any study related procedure

  • COHORT II: ≥ 18 years of age

  • COHORT II: Diagnosis of non-Hodgkin lymphoma (specifically diffuse large B-celllymphoma, 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 signan Institutional Review Board approved written informed consent form prior toreceiving any study related procedure

Exclusion

Exclusion Criteria:

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

  • 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 acholecystectomy 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 unsuitablecandidate 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 unsuitablecandidate to receive study intervention

Study Design

Total Participants: 75
Treatment Group(s): 4
Primary Treatment: Dual X-ray Absorptiometry
Phase:
Study Start date:
August 14, 2023
Estimated Completion Date:
September 01, 2026

Study Description

PRIMARY OBJECTIVE:

I. 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:

I. 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

Connect with a study center

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14263
    United States

    Site Not Available

  • Roswell Park Comprehensive Cancer Center

    Buffalo 5110629, New York 5128638 14263
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.