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

M.D. Anderson Cancer Center

Status and phase: Active, not recruiting; Phase 2

Conditions: Malignant Neoplasm; Dyspnea

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02357134

NCI-2015-00418 (Registry Identifier)

2014-0971 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 4 patient groups

Arm I (high-flow oxygen)

Experimental group

Description:

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

Treatment:

Other: Questionnaire Administration

Procedure: Oxygen Therapy

Procedure: Oxygen Therapy

Other: Quality-of-Life Assessment

Arm II (high-flow air)

Experimental group

Description:

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

Treatment:

Other: Questionnaire Administration

Procedure: Oxygen Therapy

Procedure: Oxygen Therapy

Other: Quality-of-Life Assessment

Arm III (low-flow oxygen)

Active Comparator group

Description:

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

Treatment:

Other: Questionnaire Administration

Procedure: Respiratory Therapy

Procedure: Respiratory Therapy

Other: Quality-of-Life Assessment

Arm IV (low-flow air)

Active Comparator group

Description:

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

Treatment:

Other: Questionnaire Administration

Procedure: Respiratory Therapy

Procedure: Respiratory Therapy

Other: Quality-of-Life Assessment