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Low-Intensity Mechanical Stimulation for the Prevention of Bone Mineral Density Loss in Patients Undergoing Hematopoietic Cell Transplantation

Sponsor
Roswell Park Cancer Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05893940
Collaborator
(none)
50
Enrollment
1
Arm
36
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This clinical trial tests the effect of low-intensity mechanical stimulation (LIMS) vibration therapy on bone mineral density (BMD) in patients undergoing a blood and/or bone marrow transplant (hematopoietic cell transplantation [HCT]). HCT is a curative treatment for many blood cancers and as a consequence, there are more survivors with long-term effects such as loss of BMD. BMD loss can lead to increased risk of fractures and joint replacements. The LIMS board delivers vibrations through the bones that may stimulate bone growth and may also increase muscle activity and strength and as a result may improve BMD. LIMS vibration therapy may stop or reverse BMD loss in patients undergoing HCT

Condition or Disease Intervention/Treatment Phase
  • Procedure: Low Intensity Vibration Therapy
  • Procedure: Dual X-ray Absorptiometry
  • Procedure: Biospecimen Collection
  • Other: Survey Administration
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. Determine the feasibility of delivering a low-intensity mechanical stimulation (LIMS) program immediately following hematopoietic cell transplantation (HCT).
SECONDARY OBJECTIVE:
  1. Determine the effect size of a LIMS program on bone marrow density (BMD) post-HCT.
OUTLINE:

Patients undergo LIMS vibration therapy on study. Patients also undergo dual x-ray absorptiometry (DEXA) scan at baseline and follow up and may optionally undergo blood sample collection and patient questionnaire at baseline and follow up.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Low-Intensity Mechanical Stimulation to Prevent Hematopoietic Cell Transplant-Related Bone Mineral Density Loss
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: LIMS vibration Therapy

Patients undergo LIMS vibration therapy on study. Patients also undergo DEXA scan at follow up and may optionally undergo blood sample collection and questionnaire at baseline and follow up

Procedure: Low Intensity Vibration Therapy
Undergo LIMS vibration therapy
Other Names:
  • LIV
  • Low Intensity Virbration

    • Procedure: Dual X-ray Absorptiometry
    Undergo DEXA scan
    Other Names:
  • BMD scan
  • bone mineral density scan
  • DEXA

    • Procedure: Biospecimen Collection
    Undergo blood sample collection

    Other: Survey Administration
    Complete Survey

    Outcome Measures

    Primary Outcome Measures

    1. time spent on LIMS [Up to 120 days post hematopoietic cell transplantation (HCT)]

      Will assess how much time and days use throughout study period

    Secondary Outcome Measures

    1. Change in lumbar spine bone mineral density (BMD) [Up to 120 days post - HCT]

      dual x-ray absorptiometry (DEXA) scans conducted as standard of care. BMD pre-HCT and post-HCT of patients who received LIMS compared to those who did not. A Linear regression used to compare the changes.

    2. Change in femur BMD [UP to 120 days post - HCT]

      Assessed using DEXA scans conducted as standard of care. BMD pre-HCT and post-HCT of patients who received LIMS will be compared to those who did not. A linear regression used to compare the changes.

    3. Barriers to LIMS [Up to 120 post -HCT]

      Reasons why LIMS was not used

    4. Change in patient reported outcomes [Pre HCT and at time of second DEXA: day +80]

      Short form 36 will be used to assess physical activities - comprising of 36 questions with ranges from 0 (worst) to 100 (Best)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Meet eligibility criteria for first autologous or allogeneic HCT (patients with preexisting osteoporosis are eligible)

    • Scheduled to undergo an autologous or allogeneic HCT

    • = 18 years of age

    • 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:

    • 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.)

    • Currently treated with a therapeutic dose of anti-coagulation for 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Roswell Park Cancer Institute

    Investigators

    • Principal Investigator: Megan Herr, MD, Roswell Park Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roswell Park Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT05893940
    Other Study ID Numbers:
    • I-3434822
    First Posted:
    Jun 8, 2023
    Last Update Posted:
    Jun 8, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 8, 2023