Pilot Study of Mechanical Stimulation for Prevention of Hematopoietic Cell Transplant Associated Bone Density Loss
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- Adherence with treatment
Study Overview
Brief Summary
This pilot clinical trial studies mechanical stimulation in preventing bone density loss in patients undergoing donor stem cell transplant. Mechanical stimulation may limit, prevent, or reverse bone loss, increase muscle and cardiac performance, and improve overall health
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the feasibility of a mechanical stimulation regimen in hematopoietic cell transplant (HCT) patients.
SECONDARY OBJECTIVES:
I. To evaluate the data collection tools to prepare for a larger phase II trial.
OUTLINE:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to β (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- β’Meet eligibility criteria for first allogeneic HCT, and are scheduled to undergo allogeneic HCT
- β’Pre-transplant Karnofsky Performance Status (KPS) >= 70
- β’Patient or legal representative 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
- β’Any prior allogeneic HCT
- β’Pre-transplant weight >= 280 lbs
- β’Body mass index (BMI) < l8kg/m^2
- β’Human leukocyte antigen (HLA)-mismatched HCT
- β’Cord blood transplant
- β’Osteopenia or osteoporosis (T-score =< -1.0)
- β’Multiple myeloma diagnosis
- β’Any prior history of a central nervous system (CNS) hemorrhage
- β’Currently treated with a therapeutic dose of anti-coagulation for a recent pulmonary embolism or deep vein thrombosis
- β’Current or previous bisphosphonate use
- β’Prior history of non-traumatic fracture
- β’Any screws, pins, rods, or other metal objects in the body
- β’Total joint replacement
- β’History of kidney stones or gall stones
- β’Any artificial limbs
- β’Pregnant or nursing female patients
- β’Unwilling or unable to follow protocol requirements
- β’Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study intervention
Outcomes
Primary Outcomes
Adherence with treatment
Time Frame: From hospital admission to 100 days post-HCT
Effective data collection tools and data points
Time Frame: From hospital admission to 100 days post-HCT
Refinement of mechanical stimulation protocol
Time Frame: From hospital admission to 100 days post-HCT
Best time of day for treatment, staff involvement, etc.
Secondary Outcomes
No secondary outcomes reported