Vibration therapy for patients with blood cancers
Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients
This study is testing if a special vibration therapy can help patients with blood cancers improve their bone health and immune response while they receive treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Drugs / interventions | CAR T |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT05893940 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of low-intensity mechanical stimulation (LIMS) vibration therapy on patients with hematologic malignancies, particularly those undergoing hematopoietic cell transplantation (HCT) or cellular therapy. The study aims to determine the feasibility of LIMS therapy and its impact on bone marrow density and T-cell activation. Patients are divided into two cohorts, with one receiving daily LIMS therapy and the other receiving it twice daily, alongside regular assessments of their health and treatment outcomes. The trial includes monitoring of bone density and the efficacy of CAR T-cell products in patients with Non-Hodgkin lymphoma.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with hematologic malignancies scheduled for HCT or those diagnosed with specific types of Non-Hodgkin lymphoma.
Not a fit: Patients who have previously undergone allogeneic or autologous HCT may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could enhance bone health and immune response in patients undergoing treatment for blood cancers.
How similar studies have performed: While the specific application of LIMS therapy in this context is novel, similar approaches have shown promise in other studies focused on enhancing recovery in cancer patients.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Buffalo, New York
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Megan Herr, MD — Roswell Park Comprehensive Cancer Center
- Study coordinator: Megan Herr, MD
- Email: Megan.Herr@roswellpark.org
- Phone: 716-845-3557
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.