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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00502502 |
Primary Objectives:
Condition | Intervention |
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Anal Cancer Colorectal Cancer Esophageal Cancer Gastric Cancer Lung Cancer |
Behavioral: Questionnaire |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Feasibility Study of the Assessment of Symptom-Related Cytokines in Lung and GI Cancer Patients Undergoing Chemoradiation Therapy |
Blood samples will be collected to study the levels of cytokines in your blood.
Estimated Enrollment: | 225 |
Study Start Date: | November 2002 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Questionnaire
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Behavioral: Questionnaire
Questionnaires lasting about 30 minutes.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Study participants with lung, esophageal, gastric, colorectal or anal cancer.
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T. M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Xin Shelley Wang, MD | M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( Xin Shelley Wang, MD/Associate Professor ) |
Study ID Numbers: | ANS02-495 |
Study First Received: | July 16, 2007 |
Last Updated: | February 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00502502 History of Changes |
Health Authority: | United States: Institutional Review Board |
Anal Cancer Colorectal Cancer Esophageal Cancer Gastric Cancer Lung Cancer |
Questionnaire Survey Chemoradiation Therapy Symptoms Cytokines |
Thoracic Neoplasms Gastrointestinal Diseases Rectal Neoplasms Esophageal Neoplasms Colonic Diseases Anal Cancer Rectal Diseases Stomach Diseases Respiratory Tract Diseases Lung Neoplasms Stomach Neoplasms Digestive System Neoplasms Rectal Neoplasm |
Esophageal Cancer Intestinal Diseases Intestinal Neoplasms Digestive System Diseases Rectal Cancer Esophageal Disorder Head and Neck Neoplasms Lung Diseases Gastrointestinal Neoplasms Esophageal Diseases Stomach Cancer Anus Neoplasms Colorectal Neoplasms |
Thoracic Neoplasms Respiratory Tract Neoplasms Digestive System Neoplasms Gastrointestinal Diseases Rectal Neoplasms Esophageal Neoplasms Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms Neoplasms Stomach Diseases |
Neoplasms by Site Digestive System Diseases Respiratory Tract Diseases Lung Neoplasms Lung Diseases Head and Neck Neoplasms Stomach Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Anus Diseases Anus Neoplasms Colorectal Neoplasms |