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

Not Applicable

Withdrawn

• Conditions: Adult Acute Myeloid Leukemia in Remission; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Nodal Marginal Zone B-cell Lymphoma; Noncontiguous Stage II Adult Burkitt Lymphoma; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma; Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
• Interventions: Procedure: management of therapy complications; Procedure: musculoskeletal complications management/prevention

• Registration Number: NCT01558778
• Lead Sponsor: Roswell Park Cancer Institute

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:

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).

Study Timeline

• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-20
• Study Start: 2012-05
• Primary Completion: 2012-06
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-05
• Last Update Posted: 2012-07-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (whole body vibration)	musculoskeletal complications management/prevention	Patients undergo mechanical stimulation over 20 minutes QD beginning on date of hospital admission and continuing through day 100 post-HCT, except for day 0 (date of transplant).
Supportive care (whole body vibration)	management of therapy complications	Patients undergo mechanical stimulation over 20 minutes QD beginning on date of hospital admission and continuing through day 100 post-HCT, except for day 0 (date of transplant).

Primary Outcome Measures

Name	Time	Method
Adherence with treatment	From hospital admission to 100 days post-HCT
Effective data collection tools and data points	From hospital admission to 100 days post-HCT
Refinement of mechanical stimulation protocol	From hospital admission to 100 days post-HCT	Best time of day for treatment, staff involvement, etc.