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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00186 | Registry Identifier | NCI CTRP |
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The goal of this clinical research study is to compare high-flow oxygen, low-flow oxygen, high-flow air, and low-flow air in helping to decrease shortness of breath in cancer patients. Researchers also want to learn if these therapies can help to improve lung function and quality of life.
Study Groups and Procedures:
If you agree to take part in this study, you will receive 4 different breathing therapies:
The order in which they will be given to you will be randomly assigned (as in a roll of dice). You will have an equal chance of being assigned to each group. Neither you nor the study staff will know which therapy order you are assigned to. However, if needed for your safety, the study staff will be able to find out what you are receiving.
All 4 breathing therapies should take about 80 minutes total to complete (10 minutes for each treatment with a 10 minute break between each treatment). You will receive the air or oxygen through small tubes placed in your nose. The respiratory therapist will be there to adjust the therapy to your comfort level.
At the end of each breathing therapy, you will be asked about your shortness of breath and if you have any improvement. You will also be asked if you could tell whether you received oxygen or air after each therapy.
After finishing the 4 breathing therapies, you will complete 2 questionnaires about which breathing therapy you liked and your thoughts about taking part in the study. These should take about 10 minutes total to complete.
Length of Study:
You will be taken off study if you no longer wish to take part, or if you need drugs to help with shortness of breath during the study. Your participation in the study will be over after you complete the questionnaires.
This is an investigational study. Comparing high-flow air, low-flow air, high-flow oxygen, and low-flow oxygen to treat shortness of breath is considered investigational.
Up to 36 participants will be enrolled in this study. All will take part at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-flow oxygen: Initial Therapy | Active Comparator | 4-Period crossover therapy where initial 10 minute breathing treatment with High-flow oxygen (HFOx) is followed by 3 different breathing therapies of Low-flow oxygen (LFOx), High-flow air (HFAir), and Low-flow air (LFAir) with 10 minute washout period before subsequent treatments for a total 80 minute study period accompanied by shortness of breath questionnaires. |
|
| Low-flow oxygen: Initial Therapy | Active Comparator | 4-Period crossover therapy where initial 10 minute breathing treatment with Low-flow oxygen (LFOx) is followed by 3 different breathing therapies of HFOx, HFAir, and LFAir with 10 minute washout period before subsequent treatments for a total 80 minute study period accompanied by shortness of breath questionnaires. |
|
| High-flow air: Initial Therapy | Sham Comparator | 4-Period crossover therapy where initial 10 minute breathing treatment with High-flow oxygen (LFOx) is followed by 3 different breathing therapies of HFOx, LFOx, and LFAir with 10 minute washout period before subsequent treatments for a total 80 minute study period accompanied by shortness of breath questionnaires. |
|
| Low-flow air: Initial Therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-flow Oxygen | Other | Optiflow Respiratory Humidifier used to deliver HFOx. Oxygen flow will be maximized (set between 20 and 60 L/min), if tolerated, to minimize dyspnea. FiO2 will be set at 100%. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dyspnea Numeric Score Between 0 and 10 Minutes | We assessed dyspnea intensity 'now' using a numeric rating scale from 0 to 10 where 0=none and 10=worst. The minimal clinically important difference was 1 point. | 0 (baseline) minutes and at 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Borg Scale Intensity Between 0 and 10 Minutes | We assessed dyspnea intensity 'now' using a Modified Dyspnea Borg scale. This is a 0-10 point ratio scale with a higher score indicating worse dyspnea. | 0 (baseline) minutes and at 10 minutes |
| Change in Modified Borg Scale Unpleasantness Between 0 and 10 Minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Hui, MD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33289276 | Derived | Hui D, Hernandez F, Urbauer D, Thomas S, Lu Z, Elsayem A, Bruera E. High-Flow Oxygen and High-Flow Air for Dyspnea in Hospitalized Patients with Cancer: A Pilot Crossover Randomized Clinical Trial. Oncologist. 2021 May;26(5):e883-e892. doi: 10.1002/onco.13622. Epub 2020 Dec 15. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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19 patients were randomized for this study. 7 patients were not randomized for various reasons (discharged too early=3, changed mind=2 and others =2)
Patients were recruited from MD Anderson Cancer Center with active cancer diagnosis , having age >=18, an average dyspnea numeric rating scale of ≥4/10 over the past 24 hours, oxygen saturation >90% on ambient air and able to tolerate high flow nasal canula.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx) | High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min |
| FG001 | Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir) | High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min |
| FG002 | Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx) | High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min |
| FG003 | Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir) | High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
It included all randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx) | High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min |
| BG001 | Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Dyspnea Numeric Score Between 0 and 10 Minutes | We assessed dyspnea intensity 'now' using a numeric rating scale from 0 to 10 where 0=none and 10=worst. The minimal clinically important difference was 1 point. | Participants who completed the first intervention. | Posted | Mean | 95% Confidence Interval | score on a scale | 0 (baseline) minutes and at 10 minutes |
|
baseline and 10 minutes of each intervention.
Adverse effects such as dry eyes, dry nose, nasal moisture and anxiety were assessed using a 0-10 numeric rating scale, where 0=none and 10=worst possible. The participants 'at risk' are a total number of participants combined that received specific intervention from each group at different sequences.
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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 Air | High Flow Air was delivered between 20 and 60 L/min. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Hui, MD, Associate Professor/Palliative Care Med | UT MD Anderson Cancer Center | 713-792-6258 | dhui@mdanderson.org |
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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 26, 2017 | Jul 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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4-Period crossover therapy where initial 10 minute breathing treatment with Low-flow air (LFAir) is followed by 3 different breathing therapies of HFOx, LFOx, and HFAir with 10 minute washout period before subsequent treatments for a total 80 minute study period accompanied by shortness of breath questionnaires. |
|
|
| Low-flow Oxygen | Other | Low-flow Oxygen will be delivered by Optiflow in an identical manner to high flow, except provided at 2 L/min using a nasal cannula identical to that used for high-flow devices. |
|
|
| High-flow Air | Other | Two level air flow (high and low) will be delivered by Optiflow in an identical manner to oxygen air flows, except that researchers will use pressurized air instead of oxygen. LFOx and LFAir will be provided at 2 L/min using a nasal cannula identical to that used for high-flow devices. |
|
|
| Low-flow Air | Other | Two level air flow (high and low) will be delivered by Optiflow in an identical manner to oxygen air flows, except that researchers will use pressurized air instead of oxygen. LFOx and LFAir will be provided at 2 L/min using a nasal cannula identical to that used for high-flow devices. |
|
|
We assessed dyspnea unpleasantness 'now' using a Modified Dyspnea Borg scale. This is a 0-10 point ratio scale with a higher score indicating worse dyspnea unpleasantness. |
| 0 (baseline) minutes and at 10 minutes |
| Chest pain |
|
| Not Dyspneic cough |
|
High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min |
| BG002 | Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx) | High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min |
| BG003 | Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir) | High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cancer Stage | Cancer is typically labeled in stages from I to IV, with IV being the most serious. | Count of Participants | Participants |
|
| Cancer Type | Count of Participants | Participants |
|
| Dyspnea for reason of admission | Count of Participants | Participants |
|
| Supplement Oxygen | Count of Participants | Participants |
|
| OG002 | Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx) | High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min. |
| OG003 | Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir) | High Flow Oxygen and High Flow Air was delivered between 20 and 60 L/min. Low Flow Oxygen and Low Flow Air was delivered at 2L/min. |
|
|
| Secondary | Change in Modified Borg Scale Intensity Between 0 and 10 Minutes | We assessed dyspnea intensity 'now' using a Modified Dyspnea Borg scale. This is a 0-10 point ratio scale with a higher score indicating worse dyspnea. | Participants who completed the first intervention | Posted | Mean | 95% Confidence Interval | score on a scale | 0 (baseline) minutes and at 10 minutes |
|
|
|
| Secondary | Change in Modified Borg Scale Unpleasantness Between 0 and 10 Minutes | We assessed dyspnea unpleasantness 'now' using a Modified Dyspnea Borg scale. This is a 0-10 point ratio scale with a higher score indicating worse dyspnea unpleasantness. | Participants who completed the first intervention. | Posted | Mean | 95% Confidence Interval | score on a scale | 0 (baseline) minutes and at 10 minutes |
|
|
|
| 12 |
| 0 |
| 12 |
| 7 |
| 12 |
| EG001 | High Flow Oxygen | High Flow Oxygen was delivered between 20 and 60 L/min. | 0 | 13 | 0 | 13 | 6 | 13 |
| EG002 | Low Flow Air | Low Flow Air was delivered at 2L/min. | 0 | 13 | 0 | 13 | 4 | 13 |
| EG003 | Low Flow Oxygen | Low Flow Oxygen was delivered at 2L/min. | 0 | 13 | 0 | 13 | 7 | 13 |
| Moisture in nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal prong uncomfortable | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Anxiety | Nervous system disorders | Systematic Assessment |
|
| Feeling of suffocation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Trouble talking | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dry eyes | Nervous system disorders | Systematic Assessment |
|
| Eye irritation | Nervous system disorders | Systematic Assessment |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |