Pilot Study of Mechanical Stimulation for Prevention of Hematopoietic Cell Transplant Associated Bone Density Loss
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:
Patients undergo mechanical stimulation over 20 minutes once daily (QD) beginning on date of
hospital admission and continuing through day 100 post-HCT, except for day 0 (date of
transplant).
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Refinement of mechanical stimulation protocol
Best time of day for treatment, staff involvement, etc.
From hospital admission to 100 days post-HCT
No
Philip McCarthy
Principal Investigator
Roswell Park Cancer Institute
United States: Institutional Review Board
I 190510
NCT01558778
May 2012
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