Phase II Evaluation of Exhaled Nitric Oxide as a Predictive Biomarker for Radiation Pneumonitis
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
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
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
Up to 150 patients will take part in this study. All will be enrolled at MD Anderson.
Observational Model: Cohort, Time Perspective: Prospective
Ratio Between Weekly and Baseline Nitric Oxide (NO) Measurements
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.
Weekly starting prior to start of radiation therapy to follow-up visits for 6 months.
Thomas Guerrero, MD, PHD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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