Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05893940

Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

Led by Roswell Park Cancer Institute · Updated on 2025-12-03

75

Participants Needed

1

Research Sites

159 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • COHORT I: Eligible for first autologous or allogeneic hematopoietic cell transplantation (HCT); patients with preexisting osteoporosis are allowed
  • COHORT I: Scheduled to undergo autologous or allogeneic HCT
  • COHORT I: At least 18 years old
  • COHORT I: Able to understand and sign informed consent
  • COHORT II: At least 18 years old
  • COHORT II: Diagnosed with non-Hodgkin lymphoma (diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia); patients with preexisting osteoporosis are allowed
  • COHORT II: Able to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • COHORT I: Any prior allogeneic HCT
  • COHORT I: Any prior autologous HCT if planning autologous HCT
  • COHORT I: Pre-transplant weight 275 lbs or more
  • COHORT I: Body mass index (BMI) less than 18 kg/m2
  • COHORT I: Recipient of cord blood transplant
  • COHORT I: Diagnosis of multiple myeloma or amyloidosis
  • COHORT I: History of central nervous system hemorrhage within 60 days
  • COHORT I: History of any aneurysm (cerebral, aortic, etc.)
  • COHORT I: Recent pulmonary embolism or deep vein thrombosis
  • COHORT I: Presence of a cardiac pacemaker
  • COHORT I: Prior non-traumatic (spontaneous) fracture
  • COHORT I: Total joint replacement
  • COHORT I: History of kidney or gall stones within 2 years unless gall bladder removal was done
  • COHORT I: Any prosthetic lower extremity or limb
  • COHORT I: Pregnant or nursing female
  • COHORT I: Unable or unwilling to follow protocol requirements
  • COHORT I: Any condition making the patient unsuitable for study intervention
  • COHORT II: Planned CAR T-cell therapy within 2 months
  • COHORT II: Prior CAR T-cell therapy
  • COHORT II: Active treatment within last 60 days
  • COHORT II: Pre-transplant weight 275 lbs or more
  • COHORT II: Body mass index (BMI) less than 18 kg/m2
  • COHORT II: History of central nervous system hemorrhage within 60 days
  • COHORT II: History of any aneurysm (cerebral, aortic, etc.)
  • COHORT II: Recent pulmonary embolism or deep vein thrombosis
  • COHORT II: Presence of a cardiac pacemaker
  • COHORT II: Recent non-traumatic fracture within 60 days
  • COHORT II: Recent surgery within 60 days
  • COHORT II: Pregnant or nursing female
  • COHORT II: Unable or unwilling to follow protocol requirements
  • COHORT II: Any condition making the patient unsuitable for study intervention

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States, 14263

Actively Recruiting

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Research Team

M

Megan Herr, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

2

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