Phase II Evaluation of Exhaled Nitric Oxide (NO)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Phase II Evaluation of Exhaled Nitric Oxide as a Predictive Biomarker for Radiation Pneumonitis|
- 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. ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2011|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
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.Behavioral: Questionnaires
On day of each breathing test, completion of a breathing and symptom questionnaire, approximately 10 minutes.
Other Name: Survey
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|