Mechanical Stimulation in Preventing Bone Density Loss in Patients Undergoing Donor Stem Cell Transplant

Pilot Study of Mechanical Stimulation for Prevention of Hematopoietic Cell Transplant Associated Bone Density Loss

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

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).

Inclusion Criteria:

• Meet eligibility criteria for first allogeneic HCT, and are scheduled to undergo allogeneic HCT
• Pre-transplant Karnofsky Performance Status (KPS) >= 70
• 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:

• Any prior allogeneic HCT
• Pre-transplant weight >= 280 lbs
• Body mass index (BMI) < l8kg/m^2
• Human leukocyte antigen (HLA)-mismatched HCT
• Cord blood transplant
• Osteopenia or osteoporosis (T-score =< -1.0)
• Multiple myeloma diagnosis
• Any prior history of a central nervous system (CNS) hemorrhage
• Currently treated with a therapeutic dose of anti-coagulation for a recent pulmonary embolism or deep vein thrombosis
• Current or previous bisphosphonate use
• Prior history of non-traumatic fracture
• Any screws, pins, rods, or other metal objects in the body
• Total joint replacement
• History of kidney stones or gall stones
• Any artificial limbs
• 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