Phase II Evaluation of Exhaled Nitric Oxide as a Predictive Biomarker for Radiation Pneumonitis
18 Years
N/A
Both
Lung Cancer
Trial Information
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
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 radiation 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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Ratio Between Weekly and Baseline Nitric Oxide (NO) Measurements
Outcome Description:
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.
Outcome Time Frame:
Weekly starting prior to start of radiation therapy to follow-up visits for 6 months.
Safety Issue:
No
Principal Investigator
Thomas Guerrero, MD, PHD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2010-0446
NCT ID:
NCT01392144
Start Date:
August 2011
Completion Date:
February 2013
Related Keywords:
- Lung Cancer
- Radiation pneumonitis
- RP
- Nitric oxide
- NO
- Thoracic
- Esophagus cancer
- Lung cancer
- Radiation therapy
- radiotherapy
- RT
- XRT
- Airway
- Alveolar
- Nitric oxide breath analyzer
- Questionnaires
- Lung Neoplasms
- Pneumonia
- Radiation Pneumonitis
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
