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

NCT00504920 | Completed

• 1 other identifier: 2003-0495
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myelodysplastic Syndrome; Acute Myeloblastic Leukemia; Leukemia

Keywords

Leukemia; Myelodysplastic Syndrome; Acute Myeloblastic Leukemia; Symptom-Related Cytokines; Blood or Marrow Transplantation; Questionnaire

Study Arms (1)

Symptom Assessment

Drawing blood samples and matching the test results with questionnaire responses for symptoms patients experience from transplant treatment.

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

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.

Symptom Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with a current diagnosis of psychosis or dementia
• Patients who are unable to complete the assessment measures or refuse to participate

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

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.

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Leukemia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Xin Shelley Wang, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2007
• First Posted: July 20, 2007
• Study Start: May 1, 2004
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: August 1, 2012

Record last verified: 2012-07

Locations

US (1)