Trial Outcomes & Findings for High-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer (NCT NCT02357134)
NCT ID: NCT02357134
Last Updated: 2022-12-07
Results Overview
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).
UNKNOWN
PHASE2
74 participants
End of second exercise test and end of third exercise test, approximately up to 12 minutes
2022-12-07
Participant Flow
Patients were recruited from the Supportive Care, Thoracic Radiation Oncology and Thoracic Medical Oncology clinics at MD Anderson Cancer Center, Houston, USA between 3/2015 and 4/2018 .
A total of 74 participants were enrolled but 45 patients were randomized for this study. 29 patients were not randomized for various reasons (became ineligible or too symptomatic to participate while waiting=14, scheduling conflict=9, exertional dyspnea too low=4, could not complete baseline test due to desaturation=1, hypertension during exercise=1)
Participant milestones
| Measure |
High Flow Oxygen
High Flow Oxygen were delivered between 20 and 70 L/min.
|
High Flow Air
High Flow Air were delivered between 20 and 70 L/min.
|
Low Flow Oxygen
Low Flow Oxygen were delivered at 2 L/min.
|
Low Flow Air
Low Flow Air were delivered at 2 L/min
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
12
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
High Flow Oxygen
High Flow Oxygen were delivered between 20 and 70 L/min.
|
High Flow Air
High Flow Air were delivered between 20 and 70 L/min.
|
Low Flow Oxygen
Low Flow Oxygen were delivered at 2 L/min.
|
Low Flow Air
Low Flow Air were delivered at 2 L/min
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
Baseline Characteristics
High-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer
Baseline characteristics by cohort
| Measure |
High Flow Oxygen
n=10 Participants
High Flow Oxygen were delivered between 20 and 70 L/min
|
High Flow Air
n=11 Participants
High Flow Air were delivered between 20 and 70 L/min
|
Low Flow Oxygen
n=12 Participants
Low Flow Oxygen were delivered at 2 L/min
|
Low Flow Air
n=11 Participants
Low Flow Air were delivered at 2 L/min
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59 years
n=93 Participants
|
67 years
n=4 Participants
|
63 years
n=27 Participants
|
62 years
n=483 Participants
|
63 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
18 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
40 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
38 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
11 participants
n=4 Participants
|
12 participants
n=27 Participants
|
11 participants
n=483 Participants
|
44 participants
n=36 Participants
|
|
Cancer Type
Mesothelioma
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Cancer Type
Non Small Cell Lung Cancer
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
28 Participants
n=36 Participants
|
|
Cancer Type
Small Cell Lung Cancer
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
|
Cancer Type
Other
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Cancer Stage
Localized
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
|
Cancer Stage
Locally advanced
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
17 Participants
n=36 Participants
|
|
Cancer Stage
Metastatic
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
20 Participants
n=36 Participants
|
|
Comorbidities
COPD
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
|
Comorbidities
Heart Failure
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Comorbidities
Asthma
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: End of second exercise test and end of third exercise test, approximately up to 12 minutesPopulation: The data is provided for 44 participants who completed the study.
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).
Outcome measures
| Measure |
High Flow Oxygen
n=10 Participants
High Flow Oxygen were delivered between 20 and 70 L/min
|
High Flow Air
n=11 Participants
High Flow Air were delivered between 20 and 70 L/min
|
Low Flow Oxygen
n=12 Participants
Low Flow Oxygen were delivered at 2 L/min
|
Low Flow Air
n=11 Participants
Low Flow Air were delivered at 2 L/min
|
|---|---|---|---|---|
|
Modified Borg Scale Dyspnea Intensity at Isotime
|
-1.1 score on a scale
Interval -2.1 to -0.12
|
-0.2 score on a scale
Interval -0.97 to 0.6
|
-1.8 score on a scale
Interval -2.7 to -0.9
|
-0.5 score on a scale
Interval -1.3 to 0.4
|
SECONDARY outcome
Timeframe: Third exercise test, approximately up to 12 minutesPopulation: The data is provided for 44 participants who completed the study.
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.
Outcome measures
| Measure |
High Flow Oxygen
n=10 Participants
High Flow Oxygen were delivered between 20 and 70 L/min
|
High Flow Air
n=11 Participants
High Flow Air were delivered between 20 and 70 L/min
|
Low Flow Oxygen
n=12 Participants
Low Flow Oxygen were delivered at 2 L/min
|
Low Flow Air
n=11 Participants
Low Flow Air were delivered at 2 L/min
|
|---|---|---|---|---|
|
Slope of Modified Borg Scale Dyspnea Unpleasantness Over Time During Constant Work Exercise Per Minute (Third Test)
|
0.55 Units on a scale per minute
Interval 0.5 to 0.62
|
0.78 Units on a scale per minute
Interval 0.71 to 0.87
|
0.59 Units on a scale per minute
Interval 0.52 to 0.67
|
0.69 Units on a scale per minute
Interval 0.6 to 0.79
|
SECONDARY outcome
Timeframe: Third exercise test, approximately up to 12 minutesLeg 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.
Outcome measures
| Measure |
High Flow Oxygen
n=10 Participants
High Flow Oxygen were delivered between 20 and 70 L/min
|
High Flow Air
n=11 Participants
High Flow Air were delivered between 20 and 70 L/min
|
Low Flow Oxygen
n=12 Participants
Low Flow Oxygen were delivered at 2 L/min
|
Low Flow Air
n=11 Participants
Low Flow Air were delivered at 2 L/min
|
|---|---|---|---|---|
|
Modified Borg Scale Leg Discomfort
|
0.59 Units on a scale per minute
Interval 0.53 to 0.64
|
0.91 Units on a scale per minute
Interval 0.82 to 0.99
|
0.65 Units on a scale per minute
Interval 0.58 to 0.74
|
0.81 Units on a scale per minute
Interval 0.71 to 0.91
|
SECONDARY outcome
Timeframe: End of third exercise test, approximately up to 12 minutesThe 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
Outcome measures
| Measure |
High Flow Oxygen
n=10 Participants
High Flow Oxygen were delivered between 20 and 70 L/min
|
High Flow Air
n=11 Participants
High Flow Air were delivered between 20 and 70 L/min
|
Low Flow Oxygen
n=12 Participants
Low Flow Oxygen were delivered at 2 L/min
|
Low Flow Air
n=11 Participants
Low Flow Air were delivered at 2 L/min
|
|---|---|---|---|---|
|
Exercise Endurance
|
10.50 minutes
Interval 7.48 to 13.52
|
8.18 minutes
Interval 7.03 to 9.34
|
7.58 minutes
Interval 6.0 to 9.17
|
7.36 minutes
Interval 6.35 to 8.37
|
SECONDARY outcome
Timeframe: Before and after 3rd test during intervention phase, approximately up to 12 minutesAdverse 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).
Outcome measures
| Measure |
High Flow Oxygen
n=10 Participants
High Flow Oxygen were delivered between 20 and 70 L/min
|
High Flow Air
n=11 Participants
High Flow Air were delivered between 20 and 70 L/min
|
Low Flow Oxygen
n=12 Participants
Low Flow Oxygen were delivered at 2 L/min
|
Low Flow Air
n=11 Participants
Low Flow Air were delivered at 2 L/min
|
|---|---|---|---|---|
|
Adverse Events
Dry eyes
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
0.17 units on a scale
Standard Deviation 0.94
|
0 units on a scale
Standard Deviation 0
|
|
Adverse Events
Dry Nose
|
0 units on a scale
Standard Deviation 0
|
-0.45 units on a scale
Standard Deviation 1.21
|
-.033 units on a scale
Standard Deviation 0.89
|
0.3 units on a scale
Standard Deviation 0.67
|
|
Adverse Events
Eye Irritation
|
-0.1 units on a scale
Standard Deviation 0.32
|
0 units on a scale
Standard Deviation 0
|
0.33 units on a scale
Standard Deviation 1.15
|
0 units on a scale
Standard Deviation 0
|
|
Adverse Events
Moisture in nose
|
1 units on a scale
Standard Deviation 3.8
|
0.73 units on a scale
Standard Deviation 1.56
|
0 units on a scale
Standard Deviation 1.13
|
1.5 units on a scale
Standard Deviation 2.8
|
|
Adverse Events
Nasal Prongs Uncomfortable
|
-0.3 units on a scale
Standard Deviation 0.67
|
0.18 units on a scale
Standard Deviation 0.87
|
-0.17 units on a scale
Standard Deviation 0.94
|
0.3 units on a scale
Standard Deviation 0.67
|
|
Adverse Events
Suffocating
|
0.1 units on a scale
Standard Deviation 1.2
|
-0.09 units on a scale
Standard Deviation 0.54
|
0.08 units on a scale
Standard Deviation 0.29
|
0.4 units on a scale
Standard Deviation 0.7
|
|
Adverse Events
Anxious
|
0.4 units on a scale
Standard Deviation 1.78
|
-0.55 units on a scale
Standard Deviation 1.29
|
0.17 units on a scale
Standard Deviation 0.72
|
0.5 units on a scale
Standard Deviation 1.58
|
|
Adverse Events
Difficulty talking
|
-0.1 units on a scale
Standard Deviation 0.57
|
0.09 units on a scale
Standard Deviation 0.3
|
0 units on a scale
Standard Deviation 0
|
0 units on a scale
Standard Deviation 0
|
Adverse Events
High Flow Oxygen
High Flow Air
Low Flow Oxygen
Low Flow Air
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
David Hui, MD/ Associate Professor, Palliative Care Medicine
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place