Clinical trial NCT02357134: High-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer
Official title: High-Flow Oxygen for Exertional Dyspnea in Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Dyspnea
Malignant Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-02-06
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Modified Borg Scale Dyspnea Intensity at Isotime
timeFrame: End of second exercise test and end of third exercise test, approximately up to 12 minutes
Secondary outcomes:
measure: Slope of Modified Borg Scale Dyspnea Unpleasantness Over Time During Constant Work Exercise Per Minute (Third Test)
timeFrame: Third exercise test, approximately up to 12 minutes
measure: Modified Borg Scale Leg Discomfort
timeFrame: Third exercise test, approximately up to 12 minutes
measure: Exercise Endurance
timeFrame: End of third exercise test, approximately up to 12 minutes
measure: Adverse Events
timeFrame: Before and after 3rd test during intervention phase, approximately up to 12 minutes
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David Hui
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hui D, Mahler DA, Larsson L, Wu J, Thomas S, Harrison CA, Hess K, Lopez-Mattei J, Thompson K, Gomez D, Jeter M, Lin S, Basen-Engquist K, Bruera E. High-Flow Nasal Cannula Therapy for Exertional Dyspnea in Patients with Cancer: A Pilot Randomized Clinical Trial. Oncologist. 2021 Aug;26(8):e1470-e1479. doi: 10.1002/onco.13624. Epub 2020 Dec 14.