Phase II Evaluation of Exhaled Nitric Oxide (NO)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01392144
First received: July 8, 2011
Last updated: April 1, 2013
Last verified: April 2013

July 8, 2011
April 1, 2013
August 2011
February 2013   (final data collection date for 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. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01392144 on ClinicalTrials.gov Archive Site
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Phase II Evaluation of Exhaled Nitric Oxide (NO)
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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Lung and esphageal cancer patients receiving radiation therapy, at UT MD Anderson Cancer Center in Houston, Texas

Lung Cancer
  • Procedure: Nitric oxide breath test
    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.
  • Behavioral: Questionnaires
    On day of each breathing test, completion of a breathing and symptom questionnaire, approximately 10 minutes.
    Other Name: Survey
Nitric Oxide Breath Analysis
Nitric Oxide Breath Test + Questionnaires
Interventions:
  • Procedure: Nitric oxide breath test
  • Behavioral: Questionnaires
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
February 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01392144
2010-0446, R21CA159105
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Institutes of Health (NIH)
Principal Investigator: Thomas Guerrero, MD, PHD UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP