Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients
Recruiting now · Not applicable
Conditions studied: Hematopoietic and Lymphoid System Neoplasm
In brief
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.
Key facts
- Study ID
- NCT05893940
- Run by
- Roswell Park Cancer Institute
- People needed
- 75
- Starts
- 2023-08-14
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2025-12-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- 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
Where it is running
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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