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

Leukemia Clinical Trial

Official title:

Feasibility Study of the Assessment of Symptom-Related Cytokines in AML/MDS Patients Undergoing Allogeneic Blood or Marrow Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00504920
• Other study ID #: 2003-0495
• Status: Completed
• Phase: N/A
• First received: July 18, 2007
• Last updated: July 31, 2012
• Start date: May 2004
• Est. completion date: September 2008

Study information

• Verified date: July 2012
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Myeloblastic Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia

Intervention

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.

Locations

Country	Name	City	State
United States	U.T.M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

External Links

•   UT MD Anderson Cancer Center website