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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary:

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).

Sponsor: Roswell Park Cancer Institute

Current Primary Outcome:

• Refinement of mechanical stimulation protocol [ Time Frame: From hospital admission to 100 days post-HCT ]
  Best time of day for treatment, staff involvement, etc.
• 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Roswell Park Cancer Institute

Dates:
Date Received: March 16, 2012
Date Started: May 2012
Date Completion:
Last Updated: July 5, 2012
Last Verified: July 2012