NCT05893940 · Roswell Park Cancer Institute
Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Buffalo, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 3, 2025 · Source of record for eligibility and locations