An interventional study of management of therapy complications and musculoskeletal complications management/prevention in Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission and Adult Acute Myeloid Leukemia in Remission, sponsored by Roswell Park Cancer Institute. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-09.
Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Supportive care
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
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).
209 studies on the registry are indexed under Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative; 9 are open to participants now.
Browse Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative studies →Roswell Park Cancer Institute is the lead sponsor of 419 studies on the registry; 65 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Compared within Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Leukemia, Myeloid, Accelerated Phase. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Procedure: musculoskeletal complications management/prevention
Undergo mechanical stimulation
Also known as: complications of therapy, management of
Undergo mechanical stimulation
Also known as: complications management/prevention, musculoskeletal, management/prevention, musculoskeletal complications
Refinement of mechanical stimulation protocol
Best time of day for treatment, staff involvement, etc.
Time frame: From hospital admission to 100 days post-HCT
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
No study locations are listed for this record.
The record gives a start of May 2012 and a primary completion of Jun 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative →
Roswell Park Cancer Institute →