High-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer
High-Flow Oxygen for Exertional Dyspnea in Cancer Patients
2 other identifiers
interventional
74
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2015
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2015
CompletedFirst Posted
Study publicly available on registry
February 6, 2015
CompletedStudy Start
First participant enrolled
March 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedResults Posted
Study results publicly available
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedDecember 7, 2022
November 1, 2022
5.8 years
January 29, 2015
February 18, 2021
December 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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).
End of second exercise test and end of third exercise test, approximately up to 12 minutes
Secondary Outcomes (4)
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
Modified Borg Scale Leg Discomfort
Third exercise test, approximately up to 12 minutes
Exercise Endurance
End of third exercise test, approximately up to 12 minutes
Adverse Events
Before and after 3rd test during intervention phase, approximately up to 12 minutes
Study Arms (4)
Arm I (high-flow oxygen)
EXPERIMENTALPatients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.
Arm II (high-flow air)
EXPERIMENTALPatients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session
Arm III (low-flow oxygen)
ACTIVE COMPARATORPatients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.
Arm IV (low-flow air)
ACTIVE COMPARATORPatients receive low-flow air via a nasal cannula during a structured stationary bicycle exercise session.
Interventions
Receive high-flow oxygen
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 33289280DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Hui, MD/ Associate Professor, Palliative Care Medicine
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
David Hui
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2015
First Posted
February 6, 2015
Study Start
March 17, 2015
Primary Completion
December 30, 2020
Study Completion
May 31, 2023
Last Updated
December 7, 2022
Results First Posted
June 1, 2021
Record last verified: 2022-11