NCT05893940

Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Hematopoietic and Lymphoid System Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Low Intensity Vibration Therapy	Undergo LIMS vibration therapy
PROCEDURE	Dual X-ray Absorptiometry	Undergo DEXA scan
PROCEDURE	Biospecimen Collection	Undergo blood sample collection

Timeline

• Start date: 2023-08-14
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2023-06-08
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States