Assessment of Symptom-Related Cytokines in Lung and Gastrointestinal (GI) Cancer Patients
NCT ID: NCT00502502
Last Updated: 2012-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
205 participants
OBSERVATIONAL
2002-11-30
2010-07-31
Brief Summary
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* To determine the feasibility of a study that would describe changes of certain circulating inflammatory cytokines (interleukin-1, 6, 8, 10, 12, and tumor necrosis factor-alpha \[TNF\] and symptoms related to chemoradiation therapy (pre-therapy, during therapy and up to 3 months post-therapy) among patients with lung, esophageal, gastric, colorectal and anal cancer.
* To determine the feasibility of studying neurocognitive function in patients with non-small cell lung cancer (NSCLC) at presentation and during chemoradiation therapy to determine the prevalence, severity, and pattern of cognitive symptoms.
Detailed Description
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Before therapy starts, you will be asked to complete several questionnaires during a visit to the Radiation Oncology clinic at M. D. Anderson. These questionnaires measure physical and emotional symptoms. These questionnaires should take about 30 minutes to finish. Lung cancer patients will also complete some cognitive (mental) questionnaires. 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. The date of the call will be at the same or close to the date of your weekly clinic visit.
Before you begin your chemoradiation treatments, 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 pre treatment.
You will have about 2½ tablespoons of blood drawn again when you start chemoradiation, and then once a week while you are receiving treatment. These cytokines may be related to symptoms experienced while having treatment for cancer. These blood tests are being done to study the levels of cytokines in your blood during, and after treatment for cancer.
Symptoms will be monitored weekly using an interactive voice response telephone system. During chemoradiation, 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. The information collected by these calls is only being used for this research study.
At the end of the chemoradiation, lung cancer patients will again be given questionnaires to measure cognitive symptoms.
For lung cancer patients who are post-chemotherapy, your symptoms will be monitored weekly for 3 months after therapy using the interactive voice response telephone system. For esophageal, gastric, colorectal, and anal patients who are post-therapy, your symptoms will be monitored weekly for 6 weeks after therapy using the interactive voice response telephone system. About 30 days after chemoradiation, you will have 2½ tablespoons of blood drawn at your regularly scheduled clinic visit. If you are not scheduled for a 3 month clinic visit, we will contact your local physician for blood lab results.
This is an investigational study. About 225 evaluable patients will take part in this study. All will be enrolled at M. D. Anderson.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Symptom-Related Cytokines Questionnaire
Questionnaire
Weekly questionnaires lasting about 30 minutes.
Interventions
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Questionnaire
Weekly questionnaires lasting about 30 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Adults \> 18 years of age.
3. Diagnosis of lung, esophageal, gastric, colorectal, or anal cancer.
4. English-speaking.
5. Lives in the United States.
6. Adequate vision and hearing to use the IVR system.
7. Provides written informed consent.
Exclusion Criteria
2. Patients who are unable to complete the assessment measures or refuse to participate.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Xin Shelley Wang, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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ANS02-495
Identifier Type: -
Identifier Source: org_study_id