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

July 5, 2012 updated by: Roswell Park Cancer Institute

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive care (whole body vibration)
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).
Procedure: management of therapy complications
Undergo mechanical stimulation
Other Names:
  • complications of therapy, management of
Procedure: musculoskeletal complications management/prevention
Undergo mechanical stimulation
Other Names:
  • complications management/prevention, musculoskeletal
  • management/prevention, musculoskeletal complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Refinement of mechanical stimulation protocol
Time Frame: From hospital admission to 100 days post-HCT
Best time of day for treatment, staff involvement, etc.
From hospital admission to 100 days post-HCT
Adherence with treatment
Time Frame: From hospital admission to 100 days post-HCT
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
From hospital admission to 100 days post-HCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Principal Investigator: Philip McCarthy, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 16, 2012

First Submitted That Met QC Criteria

March 19, 2012

First Posted (Estimate)

March 20, 2012

Study Record Updates

Last Update Posted (Estimate)

July 9, 2012

Last Update Submitted That Met QC Criteria

July 5, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I 190510
  • NCI-2011-02354 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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