Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504920
Status:
COMPLETED
Last Update Posted:
2012-08-01
First Post:
2007-07-18
Brief Title:
Symptom-Related Cytokines in Acute Myeloblastic Leukemia and Myelodysplastic Syndrome Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Feasibility Study of the Assessment of Symptom-Related Cytokines in AMLMDS Patients Undergoing Allogeneic Blood or Marrow Transplantation
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
1 To assess the self-reported symptoms and the plasma cytokine levels of AMLMDS 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 andor 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
1 To assess the self-reported symptoms and the plasma cytokine levels of AMLMDS 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 andor 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 andor 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 symptoms 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
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 symptoms 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None