RECRUITING

Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Low-Intensity Mechanical Stimulation for Hematologic Malignancy Patients

Quick Facts

Study Start:2023-08-14
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05893940

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * COHORT I: Meet eligibility criteria for first autologous or allogeneic HCT (patients with preexisting osteoporosis are eligible)
  2. * COHORT I: Scheduled to undergo an autologous or allogeneic HCT
  3. * COHORT 1: \>= 18 years of age
  4. * 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
  5. * 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)
  6. * 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
  1. * Any prior allogeneic HCT
  2. * Any prior autologous HCT for those patients who have a planned auto HCT
  3. * Pre-transplant weight \>= 275 lbs. (max weight for the board)
  4. * Body mass index (BMI) \< 18 kg/m\^2
  5. * Recipient of cord blood transplant
  6. * Multiple myeloma or amyloidosis diagnosis
  7. * History of a central nervous system (CNS) hemorrhage \< 60 days
  8. * History of any aneurysm (cerebral, aortic, etc.)
  9. * A recent pulmonary embolism or deep vein thrombosis
  10. * A cardiac pacemaker
  11. * Prior history of non-traumatic (spontaneous) fracture
  12. * Total joint replacement (any joint)
  13. * History of kidney stones or gall stones within the last 2 years unless a cholecystectomy was performed
  14. * Any prosthetic lower extremity or limb
  15. * Pregnant or nursing female patients
  16. * Unwilling or unable to follow protocol requirements
  17. * Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study intervention
  18. * Planned CAR T-cell therapy within the next 2 months
  19. * Prior CAR T-cell therapy
  20. * Active treatment within the last 60 days
  21. * Pre-transplant weight ≥ 275 lbs. (max weight for the board)
  22. * BMI \< 18 kg/m\^2
  23. * History of a CNS hemorrhage \< 60 days
  24. * History of any aneurysm (cerebral, aortic, etc.)
  25. * A recent pulmonary embolism or deep vein thrombosis
  26. * A cardiac pacemaker
  27. * Recent history (\< 60 days) of non-traumatic (spontaneous) fracture
  28. * Recent surgery (\< 60 days)
  29. * Pregnant or nursing female patients
  30. * Unwilling or unable to follow protocol requirements
  31. * Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study intervention

Contacts and Locations

Study Contact

Megan Herr, MD
CONTACT
716-845-3557
Megan.Herr@roswellpark.org

Principal Investigator

Megan Herr, MD
PRINCIPAL_INVESTIGATOR
Roswell Park Comprehensive Cancer Center

Study Locations (Sites)

Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
United States

Collaborators and Investigators

Sponsor: Roswell Park Cancer Institute

  • Megan Herr, MD, PRINCIPAL_INVESTIGATOR, Roswell Park Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-14
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2023-08-14
Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Hematopoietic and Lymphoid System Neoplasm