Lung CancerNCT01392144
Phase II Evaluation of Exhaled Nitric Oxide (NO)
An observational study of Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Nitric oxide breath test and Questionnaires
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung and esphageal cancer patients receiving radiation therapy, at UT MD Anderson Cancer Center in Houston, Texas
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Nitric oxide breath test, Questionnaires
- Keywords
- Radiation pneumonitis, RP, Nitric oxide, NO, Thoracic, Esophagus cancer, Lung cancer, Radiation therapy, radiotherapy, RT, XRT, Airway, Alveolar, Nitric oxide breath analyzer, Questionnaires
- Medical subject headings
- Lung Neoplasms, Radiation Pneumonitis, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric oxide breath testProcedure or surgery
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.
QuestionnairesBehavioural
Also called Survey
On day of each breathing test, completion of a breathing and symptom questionnaire, approximately 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Nitric Oxide Breath Analysis | Nitric Oxide Breath Test + Questionnaires Receives: Procedure: Nitric oxide breath test; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly starting prior to start of radiation therapy to follow-up visits for 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Thomas Guerrero, MD, PHD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392144
- Sponsor's protocol ID
- 2010-0446
- Other IDs
- R21CA159105
- Status last verified
- Apr 2013
- First submitted
- 8 Jul 2011
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation of Exhaled Nitric Oxide as a Predictive Biomarker for Radiation Pneumonitis
- ClinicalTrials.gov ID
- NCT01392144
- Acronym / sponsor ID
- 2010-0446
- Conditions
- Lung Cancer
- Keywords
- Radiation pneumonitis, RP, Nitric oxide, NO, Thoracic, Esophagus cancer, Lung cancer, Radiation therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nitric Oxide Breath Analysis | – | Procedure: Nitric oxide breath test, Behavioral: QuestionnairesNitric Oxide Breath Test + Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung and esphageal cancer patients receiving radiation therapy, at UT MD Anderson Cancer Center in Houston, Texas
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric oxide breath testBreathe 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. | Procedure or surgery | Nitric Oxide Breath Analysis |
| QuestionnairesAlso: SurveyOn day of each breathing test, completion of a breathing and symptom questionnaire, approximately 10 minutes. | Behavioural | Nitric Oxide Breath Analysis |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
- UT MD Anderson WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Guerrero, MD, PHD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013; AzTrials last refreshed its copy on 6 Nov 2026.