Back to resultsHigh-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer
Primary Purpose
Dyspnea, Malignant Neoplasm
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxygen Therapy
Oxygen Therapy
Quality-of-Life Assessment
Questionnaire Administration
Respiratory Therapy
Respiratory Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Dyspnea
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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
Arm I (high-flow oxygen)
Arm II (high-flow air)
Arm III (low-flow oxygen)
Arm IV (low-flow air)
Arm Description
Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.
Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session
Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.
Patients receive low-flow air via a nasal cannula during a structured stationary bicycle exercise session.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
Exercise Endurance
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
Adverse Events
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).
Full Information
NCT ID
NCT02357134
First Posted
January 29, 2015
Last Updated
December 5, 2022
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02357134
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 17, 2015 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea, Malignant Neoplasm
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I (high-flow oxygen)
Arm Type
Experimental
Arm Description
Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.
Arm Title
Arm II (high-flow air)
Arm Type
Experimental
Arm Description
Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session
Arm Title
Arm III (low-flow oxygen)
Arm Type
Active Comparator
Arm Description
Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.
Arm Title
Arm IV (low-flow air)
Arm Type
Active Comparator
Arm Description
Patients receive low-flow air via a nasal cannula during a structured stationary bicycle exercise session.
Intervention Type
Procedure
Intervention Name(s)
Oxygen Therapy
Other Intervention Name(s)
supplemental oxygen therapy
Intervention Description
Receive high-flow oxygen
Intervention Type
Procedure
Intervention Name(s)
Oxygen Therapy
Other Intervention Name(s)
supplemental oxygen therapy
Intervention Description
Receive high-flow air
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Respiratory Therapy
Intervention Description
Receive low-flow oxygen
Intervention Type
Procedure
Intervention Name(s)
Respiratory Therapy
Intervention Description
Receive low-flow air
Primary Outcome Measure Information:
Title
Modified Borg Scale Dyspnea Intensity at Isotime
Description
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 Outcome Measure Information:
Title
Slope of Modified Borg Scale Dyspnea Unpleasantness Over Time During Constant Work Exercise Per Minute (Third Test)
Description
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
Title
Modified Borg Scale Leg Discomfort
Description
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
Title
Exercise Endurance
Description
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
Time Frame
End of third exercise test, approximately up to 12 minutes
Title
Adverse Events
Description
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).
Time Frame
Before and after 3rd test during intervention phase, approximately up to 12 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hui
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33289280
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.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website
Learn more about this trial
High-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer
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