Accelerated Phase Chronic Myelogenous LeukemiaNCT01558778
Mechanical Stimulation in Preventing Bone Density Loss in Patients Undergoing Donor Stem Cell Transplant
A study testing management of therapy complications and musculoskeletal complications management/prevention in people with Accelerated Phase Chronic Myelogenous Leukemia and Adult Acute Lymphoblastic Leukemia in Remission, run by Roswell Park Cancer Institute.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission
- What is being tested?
- management of therapy complications and musculoskeletal complications management/prevention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
About this study
Official title: 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
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of a mechanical stimulation regimen in hematopoietic cell transplant (HCT) patients.
SECONDARY OBJECTIVES:
- 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).
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Being tested
- management of therapy complications, musculoskeletal complications management/prevention
- Medical subject headings
- Leukemia, Myeloid, Accelerated Phase, Congenital Abnormalities, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Blast Crisis, Pdgfra-Associated Chronic Eosinophilic Leukemia, Leukemia, Myelomonocytic, Chronic, Leukemia, Neutrophilic, Chronic, Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
management of therapy complicationsProcedure or surgery
Also called complications of therapy, management of
Undergo mechanical stimulation
musculoskeletal complications management/preventionProcedure or surgery
Also called complications management/prevention, musculoskeletal, management/prevention, musculoskeletal complications
Undergo mechanical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (whole body vibration) | Experimental | 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). Receives: Procedure: management of therapy complications; Procedure: musculoskeletal complications management/prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refinement of mechanical stimulation protocol
Best time of day for treatment, staff involvement, etc.
Measured: From hospital admission to 100 days post-HCT
Adherence with treatment
Measured: From hospital admission to 100 days post-HCT
Effective data collection tools and data points
Measured: From hospital admission to 100 days post-HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2012
Why it stopped: device not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accelerated Phase Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip McCarthy, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558778
- Sponsor's protocol ID
- I 190510
- Other IDs
- NCI-2011-02354
- Status last verified
- Jul 2012
- First submitted
- 16 Mar 2012
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Mechanical Stimulation for Prevention of Hematopoietic Cell Transplant Associated Bone Density Loss
- ClinicalTrials.gov ID
- NCT01558778
- Acronym / sponsor ID
- I 190510
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: device not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2012 (actual)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the feasibility of a mechanical stimulation regimen in hematopoietic cell transplant (HCT) patients.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (whole body vibration) | Experimental | Procedure: management of therapy complications, Procedure: musculoskeletal complications management/preventionPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| management of therapy complicationsAlso: complications of therapy, management ofUndergo mechanical stimulation | Procedure or surgery | Supportive care (whole body vibration) |
| musculoskeletal complications management/preventionAlso: complications management/prevention, musculoskeletal, management/prevention, musculoskeletal complicationsUndergo mechanical stimulation | Procedure or surgery | Supportive care (whole body vibration) |
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip McCarthy principal investigator
Roswell Park Cancer Institute
Questions about this trial
What is this clinical trial studying?
A study testing management of therapy complications and musculoskeletal complications management/prevention in people with Accelerated Phase Chronic Myelogenous Leukemia and Adult Acute Lymphoblastic Leukemia in Remission, run by Roswell Park Cancer Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refinement of mechanical stimulation protocol (time frame: From hospital admission to 100 days post-HCT). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2012.