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| Sponsored by: |
M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00867477 |
Purpose
Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Disease Esophageal Cancer |
Procedure: Breathing Test Behavioral: Respiratory Symptoms Questionnaire |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | A Biomarker Study Comparing the Pulmonary Metabolic Radiation Response Versus Exhaled Nitric Oxide in Patients Who Receive Thoracic Radiotherapy |
| Estimated Enrollment: | 38 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Breathing Test + Respiratory Symptoms Questionnaire
|
Procedure: Breathing Test
Exhale into NO breath analyzer for 10 seconds, repeated 3 times (before radiation therapy starts, after completing radiation therapy, and after scheduled PET scan).
Behavioral: Respiratory Symptoms Questionnaire
3 page questionnaire about breathing and any symptoms experienced, at each of 2 NO breathing tests.
|
Breathing Test:
If you agree to take part in this study, you will have a breathing test performed before starting radiation therapy, after radiation therapy is complete, as well as after your scheduled PET scan. The breathing test measures how much NO you exhale while breathing. To complete this test, you will exhale into the NO breath analyzer for 10 seconds. You will repeat this test 3 times.
The results of these test will give researchers information about possible inflammation in your lungs. The results of these tests will be compared to the results of your PET scan.
Respiratory Symptoms Questionnaire:
At each of the 2 NO breathing tests, you will be asked to complete a 3 page questionnaire about your breathing and any symptoms you may be experiencing. This is an standardized questionnaire, a research assistant will be present to help you with completing the questionnaire.
Length of Study:
After you have completed the breathing test, your participation on this study will be over.
This is an investigational study. The device (called NO breath analyzer) used in this study is FDA approved and commercially available for measuring exhaled NO levels in patients with lung cancer.
Up to 38 patients will take part in this study. All will be enrolled at M. D. Anderson.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Thomas Guerrero, MD, PhD | 713-563-2300 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Thomas Guerrero, MD, PhD | |
| Principal Investigator: | Thomas Guerrero, MD, PhD | UT MD Anderson Cancer Center |
More Information
| Responsible Party: | UT MD Anderson Cancer Center ( Thomas Guerrero, MD, PhD / Associate Professor ) |
| Study ID Numbers: | 2008-0632 |
| Study First Received: | March 20, 2009 |
| Last Updated: | March 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00867477 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Cancer of esophagus Gastrointestine esophagus cancer Positron emission tomography PET scan |
Nitric oxide NO NO Breathing Test Respiratory symptoms questionnaire |
|
Vasodilator Agents Neurotransmitter Agents Antioxidants Digestive System Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Anti-Asthmatic Agents Esophageal Cancer Cardiovascular Agents |
Nitric Oxide Digestive System Diseases Esophageal Disorder Head and Neck Neoplasms Signs and Symptoms, Respiratory Gastrointestinal Neoplasms Esophageal Diseases Peripheral Nervous System Agents Bronchodilator Agents |
|
Respiratory System Agents Neurotransmitter Agents Vasodilator Agents Antioxidants Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Esophageal Neoplasms Physiological Effects of Drugs Neoplasms by Site Therapeutic Uses Free Radical Scavengers Endothelium-Dependent Relaxing Factors Digestive System Neoplasms |
Anti-Asthmatic Agents Cardiovascular Agents Protective Agents Pharmacologic Actions Nitric Oxide Neoplasms Digestive System Diseases Autonomic Agents Head and Neck Neoplasms Gastrointestinal Neoplasms Peripheral Nervous System Agents Esophageal Diseases Bronchodilator Agents |
