Phase II Evaluation of Exhaled Nitric Oxide (NO)
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer, Cancer, Pneumonia |
Therapuetic Areas: | Oncology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | August 2011 |
Contact: | Thomas Guerrero, MD, PHD |
Phone: | 713-563-2300 |
Phase II Evaluation of Exhaled Nitric Oxide as a Predictive Biomarker for Radiation Pneumonitis
The goal of this clinical research study is to learn if the level of nitric oxide you
breathe out may relate to the amount of breathing complications that you may experience due
to radiation treatment.
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.
Inclusion Criteria:
1. Patients will sign consent for the study.
2. Patients with pathologic diagnosis of esophagus or lung cancer.
3. Patient plans to receive RT treatment at MD Anderson.
4. Patient will receive >/= 5 weeks of thoracic radiotherapy.
5. Patients >/= 18 years of age.
Exclusion Criteria:
1. Patients who have asthma.
2. Women of childbearing potential (A woman of child-bearing potential is a sexually
mature woman who has not undergone a hysterectomy or who has not been naturally
postmenopausal for at least 24 consecutive months [i.e., who has had menses at any
time in the preceding 24 consecutive months]) must practice effective contraception
(oral, injectable, or implantable hormonal contraceptive; tubal ligation;
intra-uterine device; barrier contraceptive with spermicide) throughout the study.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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