Phase II Evaluation of Exhaled Nitric Oxide (NO)
2 other identifiers
observational
36
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2011
CompletedFirst Posted
Study publicly available on registry
July 12, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedApril 4, 2013
April 1, 2013
1.5 years
July 8, 2011
April 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Weekly starting prior to start of radiation therapy to follow-up visits for 6 months.
Study Arms (1)
Nitric Oxide Breath Analysis
Nitric Oxide Breath Test + Questionnaires
Interventions
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.
Eligibility Criteria
Lung and esphageal cancer patients receiving radiation therapy, at UT MD Anderson Cancer Center in Houston, Texas
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Guerrero, MD, PHD
UT MD Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2011
First Posted
July 12, 2011
Study Start
August 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
April 4, 2013
Record last verified: 2013-04