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Feasibility Study of the Assessment of Symptom-Related Cytokines in Lung and GI Cancer Patients Undergoing Chemoradiation Therapy


N/A
18 Years
N/A
Not Enrolling
Both
Anal Cancer, Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Lung Cancer

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Trial Information

Feasibility Study of the Assessment of Symptom-Related Cytokines in Lung and GI Cancer Patients Undergoing Chemoradiation Therapy


One of the ways to learn about the symptoms of chemoradiation therapy is by looking at how
certain proteins called cytokines (found in the blood) change during therapy. Another way
is to look at how thinking and memory may be changed because of treatment.

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.


Inclusion Criteria:



1. Patients scheduled for chemoradiation therapy at MDACC.

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:

1. Patients with a current diagnosis of psychosis or dementia.

2. Patients who are unable to complete the assessment measures or refuse to participate.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Patient Symptom Assessment (Questionnaire)

Outcome Time Frame:

Weekly for 1-3 months post-therapy

Safety Issue:

No

Principal Investigator

Xin Shelley Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ANS02-495

NCT ID:

NCT00502502

Start Date:

November 2002

Completion Date:

July 2010

Related Keywords:

  • Anal Cancer
  • Colorectal Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Lung Cancer
  • Anal Cancer
  • Colorectal Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Lung Cancer
  • Questionnaire
  • Survey
  • Chemoradiation Therapy
  • Symptoms
  • Cytokines
  • Anus Neoplasms
  • Colorectal Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030