Vibration therapy for patients with blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.