Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
Pilot Study of Mechanical Stimulation for Prevention of Hematopoietic Cell Transplant Associated Bone Density Loss
| NCT number | NCT01558778 |
| Other study ID # | I 190510 |
| Secondary ID | NCI-2011-02354 |
| Status | Withdrawn |
| Phase | N/A |
| First received | March 16, 2012 |
| Last updated | July 5, 2012 |
| Start date | May 2012 |
| Verified date | July 2012 |
| Source | Roswell Park Cancer Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Roswell Park Cancer Institute |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Refinement of mechanical stimulation protocol | Best time of day for treatment, staff involvement, etc. | From hospital admission to 100 days post-HCT | No |
| Primary | Adherence with treatment | From hospital admission to 100 days post-HCT | No | |
| Primary | Effective data collection tools and data points | From hospital admission to 100 days post-HCT | No |
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