Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

NCT05893940 | Recruiting

• 1 other identifier: I-3434822
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematopoietic and Lymphoid System Neoplasm

Outcome Measures

Primary Outcomes (2)

• time spent on LIMS - Cohort I

  Will assess how much time and days use throughout study period

  Up to 120 days post hematopoietic cell transplantation (HCT)

• 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

  up to 120 days post hematopoietic cell transplantation

Secondary Outcomes (4)

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

  Up to 120 days post - HCT

• Change in femur BMD - Cohort 1

  UP to 120 days post - HCT

• Barriers to LIMS- Cohort 1

  Up to 120 post -HCT

• Change in patient reported outcomes - Cohort 1

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

Study Arms (2)

LIMS vibration Therapy, DEXA Scan - Cohort 1

EXPERIMENTAL

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

Procedure: Low Intensity Vibration Therapy; Procedure: Dual X-ray Absorptiometry; Procedure: Biospecimen Collection

LIMS vibration therapy - Cohort II

EXPERIMENTAL

Patients undergo LIMS vibration therapy over 10-minutes BID for 14 days on study. Patients also undergo blood sample collection throughout the trial.

Procedure: Low Intensity Vibration Therapy; Procedure: Biospecimen Collection

Interventions

Dual X-ray Absorptiometry PROCEDURE

Undergo DEXA scan

Also known as: BMD scan, bone mineral density scan, DEXA

LIMS vibration Therapy, DEXA Scan - Cohort 1

Biospecimen Collection PROCEDURE

Undergo blood sample collection

LIMS vibration Therapy, DEXA Scan - Cohort 1; LIMS vibration therapy - Cohort II

Low Intensity Vibration Therapy PROCEDURE

Undergo LIMS vibration therapy

Also known as: LIV, Low Intensity Virbration

LIMS vibration Therapy, DEXA Scan - Cohort 1; LIMS vibration therapy - Cohort II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 a cholecystectomy was performed
• Any prosthetic lower extremity or limb

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Interventions

Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Megan Herr, MD

  Roswell Park Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Herr, MD

CONTACT

716-845-3557; Megan.Herr@roswellpark.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: August 14, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)