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Fatigue and Its Symptom Cluster Related to Inflammatory Cytokine Profiles in Cancer Patients Seeking Emergency Care

18 Years
Not Enrolling
Advanced Cancer, Hematologic Malignancy, Fatigue

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Trial Information

Fatigue and Its Symptom Cluster Related to Inflammatory Cytokine Profiles in Cancer Patients Seeking Emergency Care

One of the ways to learn about the symptoms of cancer and the effect of cancer treatment is
by rating how severe symptoms are and how they interfere with daily activity. Researchers
can also compare these ratings to the levels of certain proteins called cytokines that are
found in the blood while the patient is experiencing symptoms.

If you agree to take part in this study, you will be asked to complete 2 surveys during your
Emergency Center visit. One survey will measure physical and mental symptoms (such as
sadness or distress). The other survey will ask you for personal "demographic" information
(such as your age and marital status). Completing the questionnaires will take about 10-15
minutes. During the Emergency Center visit, about 1 tablespoon of blood will be drawn for
cytokine testing.

Research staff will also collect other information from your medical record, clinical
information, and lab results. This information may include cancer diagnosis, cancer
treatment, performance status (your ability to perform daily activities), disease status,
and any medications you are taking at that time.

This is an investigational study. About 520 patients will participate in this study. All
will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Patients must be admitted to the Emergency Center with a diagnosis of cancer
confirmed by pathology (either hematologic malignancies or solid tumors).

2. Patients with either hematologic malignancies or solid tumors must either be
currently undergoing active cancer treatment (received chemotherapy, radiotherapy,
chemoradiotherapy, blood or bone morrow transplant, surgery, immunotherapy anytime
during the past month) or not receiving any cancer treatments in past month.

3. Patient's chief complaint upon admission to the EC must be one or more of the
following four conditions: a. fever (38.3°C or higher) in past 24 hours b. pain c.any
chemotherapy-related GI toxicities (such as nausea, vomiting, diarrhea, or
constipation) d.shortness of breath

4. Patients must be able to read and write English

5. Patients must agree to participate and must sign the Informed Consent

6. Patients must be 18 years or older (minimal numbers of children are evaluated in the

7. Patients must be able to complete the survey tool independently (without input or
influence from their caregivers).

8. Patients whose performance status allows them to complete the survey (i.e., patients
who do not have altered mental/cognitive status, and patients without emergent
illness and hemodynamic instability---for example, status epilepticus, sepsis,
cardiac arrest, and any life-threatening condition).

Exclusion Criteria:

1) Patients who were already enrolled on this protocol in a previous visit to this EC will
not be enrolled again, regardless of their reasons for the current EC visit (same or
different reason).

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Patient Fatigue Severity Scores Assessed With MDASI

Outcome Description:

Descriptive factor and cluster analysis using MD Anderson Symptom Index (MDASI) 13 core symptom items to form 1) treatment-related factor (nausea and vomiting) and 2) general severity factor (the remaining 11 core symptom items). Patients rate intensity and interference of symptoms on 0-10 numeric scales from "not present" to "as bad as you can imagine." Patients also rate the amount of interference with daily activities caused by symptoms on 0-10 numeric scales from "did not interfere" to "interfered completely."

Outcome Time Frame:

Survey and blood draw done within 24 hours of patient's Emergency Center visit

Safety Issue:


Principal Investigator

Xin Shelley Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2005

Completion Date:

April 2008

Related Keywords:

  • Advanced Cancer
  • Hematologic Malignancy
  • Fatigue
  • Advanced Cancer
  • Hematologic Malignancy
  • Fatigue
  • Emergency Center
  • Survey
  • Neoplasms
  • Emergencies
  • Fatigue
  • Hematologic Neoplasms



U.T.M.D. Anderson Cancer CenterHouston, Texas  77030