Clinical trial · Interventional
Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients
NCT05893940CI-TRIAL-00123172recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Dual X-ray Absorptiometry | Procedure | — | UNRESOLVED |
| Low Intensity Vibration Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LIMS vibration Therapy, DEXA Scan - Cohort 1
- description
- 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
- interventionNames
- Procedure: Low Intensity Vibration Therapy
- Procedure: Dual X-ray Absorptiometry
- Procedure: Biospecimen Collection
- type
- EXPERIMENTAL
- label
- LIMS vibration therapy - Cohort II
- description
- Patients undergo LIMS vibration therapy over 10-minutes BID for 14 days on study. Patients also undergo blood sample collection throughout the trial.
- interventionNames
- Procedure: Low Intensity Vibration Therapy
- Procedure: Biospecimen Collection
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.