Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

Launched by ROSWELL PARK CANCER INSTITUTE · May 30, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called low-intensity mechanical stimulation (LIMS) vibration therapy for patients with certain blood cancers, like lymphoma or those preparing for a blood or bone marrow transplant. The therapy uses a special board that delivers gentle vibrations through the bones. This may help improve bone health, strengthen muscles, and enhance the function of T-cells, which are important for fighting infections and diseases. The goal is to see if this therapy can help patients maintain better bone density and improve their immune response while they undergo treatments.

To participate in this trial, you need to be at least 18 years old and meet specific health criteria. For example, some participants will be those scheduled for a blood or bone marrow transplant. Others will have a diagnosis of certain types of lymphoma. Before joining, you’ll need to understand the study and sign a consent form. If you join, you can expect to receive the LIMS vibration therapy and be monitored for its effects on your health. It’s important to note that there are certain health conditions that may exclude you from participating, so discussing your eligibility with your healthcare provider is essential.

Gender

ALL

Eligibility criteria

• 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