High-Flow Oxygen for Exertional Dyspnea in Cancer Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Modified Borg Scale Dyspnea Intensity at Isotime
研究概览
简要总结
This randomized phase II trial studies how well high-flow oxygen works in reducing difficulty breathing during exercise (exertional dyspnea) in patients with cancer. Dyspnea is linked to decreased lung function, quality of life, and survival. High-flow oxygen is a device that delivers heated and humidified oxygen through the nose. This may be effective in reducing dyspnea, and may help patients' lungs function better and improve their quality of life.
详细描述
PRIMARY OBJECTIVES:
I. Obtain preliminary estimates of the effect size of oxygen and high flow rate on exertional dyspnea (modified Borg Scale adjusted for work rate and baseline dyspnea).
SECONDARY OBJECTIVES:
I. Determine the completion rate of a randomized controlled trial of exertional dyspnea in cancer patients.
II. Obtain preliminary estimates of the effects of oxygen and flow rate on physiologic function (respiratory rate and oxygen saturation) and exercise capacity (work rate and exercise duration).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Diagnosis of cancer, with evidence of primary or secondary lung involvement
- •Average dyspnea Borg Scale >= 4 of 10 with severe exertion over the past week
- •Oxygen saturation > 90% on ambient air at time of assessment
- •Able to communicate in English or Spanish
- •Karnofsky performance status >= 50%
- •Seen at Supportive Care, cardiopulmonary center, thoracic radiation oncology or thoracic medical oncology
排除标准
- •Resting dyspnea modified Borg Scale > 7 of 10 at enrollment
- •Severe obstructive lung disease (forced expiratory volume in 1 second [FEV1]/forced vital capacity [FVC] < 70% post bronchodilator and forced expiratory volume in 1 second < 30% predicted)
- •Delirium (i.e., Memorial Delirium Rating Scale > 13)
- •History of unstable angina or myocardial infarction in the last week
- •Acute pulmonary embolus or pulmonary infarction in the last week
- •Thrombosis of lower extremities in the last week
- •Acute myocarditis, pericarditis, or endocarditis in the last week
- •Symptomatic aortic stenosis or syncope in the last week
- •Suspected dissecting aneurysm
- •Severe untreated resting arterial hypertension (> 200 mmHg systolic, > 120 mmHg diastolic) at the time of enrollment
- •Uncontrolled arrhythmias causing symptoms or hemodynamic compromise in the last week
- •Uncontrolled heart failure in the last week
- •Pleural effusion requiring thoracentesis within 1 week of study enrollment or scheduled during the study period
- •Airway obstruction requiring stenting within 1 week of study enrollment or scheduled during the study period
- •Pneumonia requiring antibiotics at the time of study enrollment
研究组 & 干预措施
Arm I (high-flow oxygen)
Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.
干预措施: Quality-of-Life Assessment (Other)
Arm I (high-flow oxygen)
Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.
干预措施: Questionnaire Administration (Other)
Arm II (high-flow air)
Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session
干预措施: Quality-of-Life Assessment (Other)
Arm II (high-flow air)
Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session
干预措施: Questionnaire Administration (Other)
Arm III (low-flow oxygen)
Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.
干预措施: Quality-of-Life Assessment (Other)
Arm III (low-flow oxygen)
Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.
干预措施: Questionnaire Administration (Other)
Arm III (low-flow oxygen)
Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.
干预措施: Respiratory Therapy (Procedure)
Arm IV (low-flow air)
Patients receive low-flow air via a nasal cannula during a structured stationary bicycle exercise session.
干预措施: Quality-of-Life Assessment (Other)
Arm IV (low-flow air)
Patients receive low-flow air via a nasal cannula during a structured stationary bicycle exercise session.
干预措施: Questionnaire Administration (Other)
Arm IV (low-flow air)
Patients receive low-flow air via a nasal cannula during a structured stationary bicycle exercise session.
干预措施: Respiratory Therapy (Procedure)
Arm II (high-flow air)
Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session
干预措施: Oxygen Therapy (Procedure)
Arm I (high-flow oxygen)
Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.
干预措施: Oxygen Therapy (Procedure)
结局指标
主要结局
Modified Borg Scale Dyspnea Intensity at Isotime
时间窗: End of second exercise test and end of third exercise test, approximately up to 12 minutes
Assessed Dyspnea using the Modified Borg Scale Dyspnea Intensity that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath") at Isotime. Measured the mean difference of Modified Borg Scale Dyspnea Intensity at isotime between the second exercise test (in which all patients received Low Flow Oxygen) and the third exercise tests (in which all patients received the assigned intervention).
次要结局
- Slope of Modified Borg Scale Dyspnea Unpleasantness Over Time During Constant Work Exercise Per Minute (Third Test)(Third exercise test, approximately up to 12 minutes)
- Adverse Events(Before and after 3rd test during intervention phase, approximately up to 12 minutes)
- Modified Borg Scale Leg Discomfort(Third exercise test, approximately up to 12 minutes)
- Exercise Endurance(End of third exercise test, approximately up to 12 minutes)