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Clinical Trial Summary

1. To describe fatigue severity and its related symptom clusters in cancer patients who are seeking emergency care for fever, pain, shortness of breath, or cancer therapy-related gastrointestinal toxicities.

2. To describe inflammatory cytokine profiles in cancer patients who are seeking emergency care for fever, pain, shortness of breath, or cancer therapy-related gastrointestinal toxicities.

3. To determine the type of cytokines that are associated with fatigue severity in cancer patients, with or without cancer treatment, in the early phase of infection, as well as in patients with pain, shortness of breath, or cancer therapy-related gastrointestinal toxicities.


Clinical Trial Description

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. ;


Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT00504985
Study type Observational
Source M.D. Anderson Cancer Center
Contact
Status Terminated
Phase N/A
Start date August 2005
Completion date April 2008

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