High-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer

Phase 2

Active, not recruiting

Conditions: Dyspnea
Malignant Neoplasm

Interventions: Other: Quality-of-Life Assessment
Procedure: Oxygen Therapy
Other: Questionnaire Administration
Procedure: Respiratory Therapy

Registration Number: NCT02357134

Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed Description: 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).

OUTLINE: All patients undergo a baseline structured exercise session with air. Patients are then randomized to 1 of 4 treatments for a second session approximately 3 days later.

ARM I: Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.

ARM II: Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session.

ARM III: Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.

ARM IV: Patients receive low-flow air via a nasal cannula during structured stationary bicycle exercise session.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 74

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm III (low-flow oxygen)	Quality-of-Life Assessment	Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.
Arm I (high-flow oxygen)	Quality-of-Life Assessment	Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.
Arm II (high-flow air)	Quality-of-Life Assessment	Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session
Arm III (low-flow oxygen)	Respiratory Therapy	Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.
Arm IV (low-flow air)	Respiratory Therapy	Patients receive low-flow air via a nasal cannula during a structured stationary bicycle exercise session.
Arm IV (low-flow air)	Questionnaire Administration	Patients receive low-flow air via a nasal cannula during a structured stationary bicycle exercise session.
Arm I (high-flow oxygen)	Oxygen Therapy	Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.
Arm I (high-flow oxygen)	Questionnaire Administration	Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.
Arm II (high-flow air)	Oxygen Therapy	Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session
Arm III (low-flow oxygen)	Questionnaire Administration	Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.
Arm IV (low-flow air)	Quality-of-Life Assessment	Patients receive low-flow air via a nasal cannula during a structured stationary bicycle exercise session.
Arm II (high-flow air)	Questionnaire Administration	Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session

Primary Outcome Measures

Name	Time	Method
Modified Borg Scale Dyspnea Intensity at Isotime	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).

Secondary Outcome Measures

Name	Time	Method
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	Dyspnea unpleasantness was measured using the Modified Borg Scale Dyspnea Intensity that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Dyspnea intensity was measured every minute. The number of minutes varied by patient, per test. It was measured as pairwise difference of slope (taking 'low flow air' arm as a reference). This linear mixed model was constructed based on the following: Dyspnea Unpleasantness at third test = Minutes + Study Arm + Study Arm\*Minutes + Total work rate + Slope of Dyspnea Unpleasantness and Minutes at Second test + Minutes at second test.
Adverse Events	Before and after 3rd test during intervention phase, approximately up to 12 minutes	Adverse effects related to supplemental oxygen use were assessed using a numeric rating scale from 0 (not at all) to 10 (worst possible) before and after the study intervention. The mean change was measured before and after the 3rd test ranging between -10 (improvement) and +10 (deterioration).
Modified Borg Scale Leg Discomfort	Third exercise test, approximately up to 12 minutes	Leg discomfort was measured using the Modified Borg Scale Leg discomfort that ranges from 0 ("no discomfort") to 10 ("worst possible discomfort") during the constant work exercise of third test. Leg discomfort was measured every minute. The number of minutes varied by patient, per test. It was measured as pairwise difference of slope (taking 'low flow air' arm as a reference). This linear mixed model was constructed based on the following: Leg Discomfort at third test = Minutes + Study Arm + Study Arm\*Minutes + Total work rate + Slope of Leg Discomfort and Minutes at Second test + Minutes at Second test.
Exercise Endurance	End of third exercise test, approximately up to 12 minutes	The Exercise endurance was measured as a mean duration of constant work in minutes during third test. It was measured as pairwise comparison of mean difference of exercise duration (taking 'low flow air' as a reference). This linear mixed model was constructed based on the following: Time at third test = Study Arm + Minutes at Second test. Detail output from the mixed models