Myelodysplastic SyndromeNCT00504920
Symptom-Related Cytokines in Acute Myeloblastic Leukemia and Myelodysplastic Syndrome Patients
An observational study of Myelodysplastic Syndrome and Acute Myeloblastic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: 1. To assess the self-reported symptoms and the plasma cytokine levels of AML/MDS patients pretransplantation and posttransplantation with allogeneic blood and marrow in order to identify changes in symptoms (or symptom clusters) and changes in cytokines that may be related to the conditioning… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome, Acute Myeloblastic Leukemia, Leukemia
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Sep 2008
- Phase
- Observational
- 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
Study population: Patients, over 18 years, scheduled for allogeneic translantation (bone marrow or peripheral blook stem cell) at UT MD Anderson Cancer Center.
Who may be able to join
- Patients scheduled for allogeneic transplantation (bone marrow or peripheral blood stem cell) at MDACC.
- Adults > = 18 years old.
- Patients with a diagnosis of AML or MDS
- Patients who are English-speaking
- Patients who live in the United States
- Patients with adequate vision and hearing to use the interactive voice response (IVR) telephone system
- Patients who provide written informed consent/authorization
Who cannot join
- Patients with a current diagnosis of psychosis or dementia
- Patients who are unable to complete the assessment measures or refuse to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Feasibility Study of the Assessment of Symptom-Related Cytokines in AML/MDS Patients Undergoing Allogeneic Blood or Marrow Transplantation
Primary Objective:
- To assess the self-reported symptoms and the plasma cytokine levels of AML/MDS patients pretransplantation and posttransplantation with allogeneic blood and marrow in order to identify changes in symptoms (or symptom clusters) and changes in cytokines that may be related to the conditioning regimen and/or to the development of GVHD during the 100 days posttransplant.
Based on the current literature, both animal and human research, in this study we hypothesize that increases in TNF alpha to be associated with poor appetite, sleep disturbance and fatigue, but not with increases in pain, depression and numbness.
Read the detailed description
One of the ways to learn about the symptoms of blood and/or bone marrow transplantation is by looking at how certain proteins called cytokines (found in the blood) change during treatment.
Before the transplantation, you will be asked to complete several questionnaires during a visit to the bone marrow clinic at M. D. Anderson. These questionnaires measure physical and emotional symptoms. The questionnaires should take about 30 minutes to complete. During this visit, the research nurse will teach you how to use the telephone system for measuring symptoms. You will tell the system the most convenient times for the telephone calls. This first assessment (questionnaires and learning the telephone system) should take about 90 minutes.
On the day you are admitted, or up to 10 days before your admission for your transplant, you will have a sample of blood drawn (around 2½ tablespoons) . The sample of blood will be used to measure levels of cytokines in your blood before the transplant procedure. You will also have blood drawn about three days postadmission, on the day of transplant, 1 day after transplant, 3 days, 8 days, 15 days, 22 days, and 29 days posttransplant. One blood sample will be taken between 50 - 60 days posttransplant and one sample between 80 - 100 days after transplant. If you develop Graft Versus Host Disease (GVHD), cytokine samples will be assessed within 24 hours of GVHD diagnosis, then 3 days, 5 days, 10 days and 15 days after GVHD diagnosis. Around 2½ tablespoons of blood will be collected each time. These samples of blood will be used to measure the levels of cytokines in your blood after the transplant procedure. These cytokines may be related to symptoms experienced after the transplant procedure.
The research nurse will come to your room and collect information about your symptoms 2 times a week while you are in the hospital or until you are able to use the IVR system. Once you return to your home, the automated telephone system will call you once a week to ask you to rate your symptoms and how much the symptoms interfere in your daily life. It should take around 5 minutes to complete each automated phone symptom assessment.
The information collected by these calls is only being used for this research study. At the beginning of each IVR telephone call, you will be reminded to report any symptom/s you are concerned about to your treating physician.
This is an investigational study. Up to 40 participants will take part in this study. All will be enrolled at M. D. Anderson.
- Being tested
- Questionnaire
- Keywords
- Leukemia, Myelodysplastic Syndrome, Acute Myeloblastic Leukemia, Symptom-Related Cytokines, Blood or Marrow Transplantation, Questionnaire
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myeloid, Acute, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Questionnaires (30 minutes each) + instruction on telephone survey system for measuring symptoms. Questionnaires 2 times a week while in the hospital or until able to use the telephone survey system.
| Study group | Role | What they receive |
|---|---|---|
| Symptom Assessment | Drawing blood samples and matching the test results with questionnaire responses for symptoms patients experience from transplant treatment. Receives: Behavioral: Questionnaire |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study startMay 2004
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xin Shelley Wang, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504920
- Sponsor's protocol ID
- 2003-0495
- Status last verified
- Jul 2012
- First submitted
- 18 Jul 2007
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Assessment of Symptom-Related Cytokines in AML/MDS Patients Undergoing Allogeneic Blood or Marrow Transplantation
- ClinicalTrials.gov ID
- NCT00504920
- Acronym / sponsor ID
- 2003-0495
- Keywords
- Leukemia, Myelodysplastic Syndrome, Acute Myeloblastic Leukemia, Symptom-Related Cytokines, Blood or Marrow Transplantation, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 20 Jul 2007 (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.
Primary Objective:
- To assess the self-reported symptoms and the plasma cytokine levels of AML/MDS patients pretransplantation and posttransplantation with allogeneic blood and marrow in order to identify changes in symptoms (or symptom clusters) and changes in cytokines that may be related to the conditioning regimen and/or to the development of GVHD during the 100 days posttransplant.
Based on the current literature, both animal and human research, in this study we hypothesize that increases in TNF alpha to be associated with poor appetite, sleep disturbance and fatigue, but not with increases in pain, depression and numbness.
Detailed description
One of the ways to learn about the symptoms of blood and/or bone marrow transplantation is by looking at how certain proteins called cytokines (found in the blood) change during treatment.
Before the transplantation, you will be asked to complete several questionnaires during a visit to the bone marrow clinic at M. D. Anderson. These questionnaires measure physical and emotional symptoms. The questionnaires should take about 30 minutes to complete. During this visit, the research nurse will teach you how to use the telephone system for measuring symptoms. You will tell the system the most convenient times for the telephone calls. This first assessment (questionnaires and learning the telephone system) should take about 90 minutes.
On the day you are admitted, or up to 10 days before your admission for your transplant, you will have a sample of blood drawn (around 2½ tablespoons) . The sample of blood will be used to measure levels of cytokines in your blood before the transplant procedure. You will also have blood drawn about three days postadmission, on the day of transplant, 1 day after transplant, 3 days, 8 days, 15 days, 22 days, and 29 days posttransplant. One blood sample will be taken between 50 - 60 days posttransplant and one sample between 80 - 100 days after transplant. If you develop Graft Versus Host Disease (GVHD), cytokine samples will be assessed within 24 hours of GVHD diagnosis, then 3 days, 5 days, 10 days and 15 days after GVHD diagnosis. Around 2½ tablespoons of blood will be collected each time. These samples of blood will be used to measure the levels of cytokines in your blood after the transplant procedure. These cytokines may be related to symptoms experienced after the transplant procedure.
The research nurse will come to your room and collect information about your symptoms 2 times a week while you are in the hospital or until you are able to use the IVR system. Once you return to your home, the automated telephone system will call you once a week to ask you to rate your symptoms and how much the symptoms interfere in your daily life. It should take around 5 minutes to complete each automated phone symptom assessment.
The information collected by these calls is only being used for this research study. At the beginning of each IVR telephone call, you will be reminded to report any symptom/s you are concerned about to your treating physician.
This is an investigational study. Up to 40 participants will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptom Assessment | – | Behavioral: QuestionnaireDrawing blood samples and matching the test results with questionnaire responses for symptoms patients experience from transplant treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, over 18 years, scheduled for allogeneic translantation (bone marrow or peripheral blook stem cell) at UT MD Anderson Cancer Center.
Key inclusion criteria (7 listed)
- Patients scheduled for allogeneic transplantation (bone marrow or peripheral blood stem cell) at MDACC.
- Adults > = 18 years old.
- Patients with a diagnosis of AML or MDS
- Patients who are English-speaking
- Patients who live in the United States
Key exclusion criteria (2 listed)
- Patients with a current diagnosis of psychosis or dementia
- Patients who are unable to complete the assessment measures or refuse to participate
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 |
|---|---|---|
| QuestionnaireQuestionnaires (30 minutes each) + instruction on telephone survey system for measuring symptoms. Questionnaires 2 times a week while in the hospital or until able to use the telephone survey system. | Behavioural | Symptom Assessment |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Xin Shelley Wang, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndrome and Acute Myeloblastic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 1 Aug 2012.