Phase II Evaluation of Exhaled Nitric Oxide (NO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01392144|
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : April 4, 2013
|Condition or disease||Intervention/treatment|
|Lung Cancer||Procedure: Nitric oxide breath test Behavioral: Questionnaires|
Nitric Oxide Breathing Test:
If you agree to take part in this study, you will have a nitric oxide breathing test performed before, during and after radiation therapy. You will you will have a nitric oxide breathing test 1 week before you complete radiation therapy, when you complete radiation therapy, and at each follow-up visit for 6 months.
To complete this test, you will breathe out into a device called a nitric oxide breath analyzer for 10 seconds. You will repeat this test 3 times. The results of this test will give researchers information about possible inflammation in your lungs. The results of this test will be compared with any breathing symptoms you may experience during the same time period.
For your first breath testing session and any session when your nitric oxide level is at least 1 ½ times higher than the first session, you will repeat the test for up to 5 different "breathe out rates". This additional testing will allow the researchers to find where in your lungs the nitric oxide increase is coming from.
Breathing Symptoms Questionnaire:
On the day of each breathing test, you will complete a questionnaire about your breathing and any symptoms you may be experiencing. This should take about 10 minutes. After radiation therapy is complete, some of the monthly questionnaires will be completed by the data coordinator using telephone interviews.
Length of Study:
Your participation in this study will be over after you complete the last breath testing session.
This is an investigational study. The nitric oxide breath analyzer used in this study is FDA approved and commercially available for measuring breathed out nitric oxide levels in patients with asthma. Its use to predict lung inflammation caused by radiation therapy is investigational.
Up to 150 patients will take part in this study. All will be enrolled at MD Anderson.
|Study Type :||Observational|
|Actual Enrollment :||36 participants|
|Official Title:||Phase II Evaluation of Exhaled Nitric Oxide as a Predictive Biomarker for Radiation Pneumonitis|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Nitric Oxide Breath Analysis
Nitric Oxide Breath Test + Questionnaires
Procedure: Nitric oxide breath test
Breathe out into a device (nitric oxide breath analyzer) for 10 seconds; repeated 3 times. Done prior to start of radiation therapy, 1 week before completion of radiation therapy, at completion of radiation therapy, then at each follow-up visit for 6 months.
On day of each breathing test, completion of a breathing and symptom questionnaire, approximately 10 minutes.
Other Name: Survey
- Ratio Between Weekly and Baseline Nitric Oxide (NO) Measurements [ Time Frame: Weekly starting prior to start of radiation therapy to follow-up visits for 6 months. ]Ratio between weekly and baseline nitric oxide measurements in participants receiving thoracic radiation therapy. Exhaled nitric oxide measured in triplicate on a weekly basis during radiotherapy and on each follow-up visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392144
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Thomas Guerrero, MD, PHD||UT MD Anderson Cancer Center|