High-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer
Condition: Dyspnea; Malignant Neoplasm
MeSH terms: Neoplasms; Dyspnea
Intervention: Oxygen Therapy; Oxygen Therapy; Quality-of-Life Assessment; Questionnaire Administration; Respiratory Therapy; Respiratory Therapy
Intervention description: Receive high-flow oxygen; Receive high-flow air; Ancillary studies; Ancillary studies; Receive low-flow oxygen; Receive low-flow air
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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