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

M.D. Anderson Cancer Center74 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Dyspnea Malignant Neoplasm

Interventions

Oxygen TherapyPROCEDURE

Receive high-flow oxygen

Oxygen TherapyPROCEDURE

Receive high-flow air

Quality-of-Life AssessmentOTHER

Ancillary studies

Questionnaire Administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Modified Borg Scale Dyspnea Intensity at Isotime

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).

Time frame: End of second exercise test and end of third exercise test, approximately up to 12 minutes

Secondary Outcomes

Slope of Modified Borg Scale Dyspnea Unpleasantness Over Time During Constant Work Exercise Per Minute (Third Test)

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.

Time frame: Third exercise test, approximately up to 12 minutes

Modified Borg Scale Leg Discomfort

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.

Time frame: Third exercise test, approximately up to 12 minutes

Data from ClinicalTrials.gov

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