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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00418 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2014-0971 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (high-flow oxygen) | Experimental | Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session. |
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| Arm II (high-flow air) | Experimental | Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session |
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| Arm III (low-flow oxygen) | Active Comparator | Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session. |
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| Arm IV (low-flow air) | Active Comparator | Patients receive low-flow air via a nasal cannula during a structured stationary bicycle exercise session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen Therapy | Procedure | Receive high-flow oxygen |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Hui | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33289280 | Derived | 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. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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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)
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 .
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| ID | Title | Description |
|---|---|---|
| FG000 | High Flow Oxygen | High Flow Oxygen were delivered between 20 and 70 L/min. |
| FG001 | High Flow Air | High Flow Air were delivered between 20 and 70 L/min. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 17, 2018 |
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| Oxygen Therapy | Procedure | Receive high-flow air |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Respiratory Therapy | Procedure | Receive low-flow oxygen |
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| Respiratory Therapy | Procedure | Receive low-flow air |
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| Third exercise test, approximately up to 12 minutes |
| 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. | Third exercise test, approximately up to 12 minutes |
| 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 | End of third exercise test, approximately up to 12 minutes |
| 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). | Before and after 3rd test during intervention phase, approximately up to 12 minutes |
| FG002 | Low Flow Oxygen | Low Flow Oxygen were delivered at 2 L/min. |
| FG003 | Low Flow Air | Low Flow Air were delivered at 2 L/min |
| COMPLETED |
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| NOT COMPLETED |
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The data is provided for 44 participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | High Flow Oxygen | High Flow Oxygen were delivered between 20 and 70 L/min |
| BG001 | High Flow Air | High Flow Air were delivered between 20 and 70 L/min |
| BG002 | Low Flow Oxygen | Low Flow Oxygen were delivered at 2 L/min |
| BG003 | Low Flow Air | Low Flow Air were delivered at 2 L/min |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Cancer Type | Count of Participants | Participants |
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| Cancer Stage | Count of Participants | Participants |
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| Comorbidities | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The data is provided for 44 participants who completed the study. | Posted | Mean | 95% Confidence Interval | score on a scale | End of second exercise test and end of third exercise test, approximately up to 12 minutes |
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| Secondary | 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. | The data is provided for 44 participants who completed the study. | Posted | Mean | 95% Confidence Interval | Units on a scale per minute | Third exercise test, approximately up to 12 minutes |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | Units on a scale per minute | Third exercise test, approximately up to 12 minutes |
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| Secondary | 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 | Posted | Mean | 95% Confidence Interval | minutes | End of third exercise test, approximately up to 12 minutes |
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| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | Before and after 3rd test during intervention phase, approximately up to 12 minutes |
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before and after 3rd test during intervention phase, approximately up to 12 minutes
In this protocol, the Adverse events were not measured as an absolute number. It was measured as a numeric rating score from 0 (not at all) to 10 (worst possible). So there are no Adverse events numbers in the Adverse Events section. As per the protocol, Adverse events were considered as a secondary outcome. Please see 'Adverse Events' under 'Outcome Measure.'
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Flow Oxygen | High Flow Oxygen were delivered between 20 and 70 L/min | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | High Flow Air | High Flow Air were delivered between 20 and 70 L/min | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Low Flow Oxygen | Low Flow Oxygen were delivered at 2 L/min | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Low Flow Air | Low Flow Air were delivered at 2 L/min | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Hui, MD/ Associate Professor, Palliative Care Medicine | UT MD Anderson Cancer Center | (713) 792-6258 | dhui@mdanderson.org |
| Feb 10, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D004417 | Dyspnea |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| D012138 | Respiratory Therapy |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
| D013812 | Therapeutics |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Non Small Cell Lung Cancer |
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| Small Cell Lung Cancer |
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| Other |
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| Locally advanced |
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| Metastatic |
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| Heart Failure |
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| Asthma |
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| OG003 | Low Flow Air | Low Flow Air were delivered at 2 L/min |
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Low Flow Air were delivered at 2 L/min
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