Phase II Evaluation of Exhaled Nitric Oxide as a Predictive Biomarker for Radiation Pneumonitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Ratio Between Weekly and Baseline Nitric Oxide (NO) Measurements
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Ratio Between Weekly and Baseline Nitric Oxide (NO) Measurements
时间窗: 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.
次要结局
未报告次要终点