Recruiting

Low-Intensity Mechanical Stimulation

Sponsor:

Roswell Park Cancer Institute

Code:

NCT05893940

Conditions

Hematopoietic and Lymphoid System Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Low Intensity Vibration Therapy

Dual X-ray Absorptiometry

Biospecimen Collection

Study Details

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

Study ID

NCT05893940

Start date

Aug 14, 2023

Status verified date

Aug, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

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 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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: LIMS vibration Therapy, DEXA Scan - Cohort 1

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

experimental: LIMS vibration therapy - Cohort II

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

Interventions

Low Intensity Vibration Therapy

Undergo LIMS vibration therapy

Dual X-ray Absorptiometry

Undergo DEXA scan

Biospecimen Collection

Undergo blood sample collection

Primary outcome measure

  • time spent on LIMS - Cohort I [ Time Frame: Up to 120 days post hematopoietic cell transplantation (HCT) ]
  • Chimeric antigen receptor (CAR) T-cell product efficacy - Cohort II [ Time Frame: up to 120 days post hematopoietic cell transplantation ]

Central Contacts and Locations

Central contacts

Megan Herr, MD

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

Locations

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14263

Contacts

Megan Herr, MD

877-275-7724askroswell@roswellpark.org

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-08-21.