Phase II Evaluation of Exhaled Nitric Oxide (NO)
Phase II Evaluation of Exhaled Nitric Oxide as a Predictive Biomarker for Radiation Pneumonitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- UT MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients will sign consent for the study.
- Patients with pathologic diagnosis of esophagus or lung cancer.
- Patient plans to receive radiation treatment at MD Anderson.
- Patient will receive >/= 5 weeks of thoracic radiotherapy.
- Patients >/= 18 years of age.
Exclusion Criteria:
- Patients who have asthma.
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Nitric Oxide Breath Analysis
Nitric Oxide Breath Test + Questionnaires
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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Weekly starting prior to start of radiation therapy to follow-up visits for 6 months.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Thomas Guerrero, MD, PHD, UT MD Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Wounds and Injuries
- Lung Diseases, Interstitial
- Lung Injury
- Radiation Injuries
- Radiation Pneumonitis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Antioxidants
- Free Radical Scavengers
- Endothelium-Dependent Relaxing Factors
- Gasotransmitters
- Nitric Oxide
Other Study ID Numbers
- 2010-0446
- R21CA159105 (Other Identifier: NIH)
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