Symptom-Related Cytokines in Acute Myeloblastic Leukemia and Myelodysplastic Syndrome Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00504920
First received: July 18, 2007
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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 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.


Condition Intervention
Myelodysplastic Syndrome
Acute Myeloblastic Leukemia
Leukemia
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility Study of the Assessment of Symptom-Related Cytokines in AML/MDS Patients Undergoing Allogeneic Blood or Marrow Transplantation

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Biospecimen Retention:   Samples With DNA

At admission, blood sample drawn (around 2½ tablespoons) to measure levels of cytokines before transplant procedure, then another three days postadmission, on day of transplant, 1 day after transplant, 3 days, 8 days, 15 days, 22 days, 29 days postransplant, then between 50 - 60 days postransplant and again 80 - 100 days after transplant.


Enrollment: 30
Study Start Date: May 2004
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Symptom Assessment
Drawing blood samples and matching the test results with questionnaire responses for symptoms patients experience from transplant treatment.
Behavioral: Questionnaire
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients, over 18 years, scheduled for allogeneic translantation (bone marrow or peripheral blook stem cell) at UT MD Anderson Cancer Center.

Criteria

Inclusion Criteria:

  1. Patients scheduled for allogeneic transplantation (bone marrow or peripheral blood stem cell) at MDACC.
  2. Adults > = 18 years old.
  3. Patients with a diagnosis of AML or MDS
  4. Patients who are English-speaking
  5. Patients who live in the United States
  6. Patients with adequate vision and hearing to use the interactive voice response (IVR) telephone system
  7. Patients who provide written informed consent/authorization

Exclusion Criteria:

  1. Patients with a current diagnosis of psychosis or dementia
  2. Patients who are unable to complete the assessment measures or refuse to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504920

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Xin Shelley Wang, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00504920     History of Changes
Other Study ID Numbers: 2003-0495
Study First Received: July 18, 2007
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Myelodysplastic Syndrome
Acute Myeloblastic Leukemia
Symptom-Related Cytokines
Blood or Marrow Transplantation
Questionnaire

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on July 29, 2014