CancerPhase 2NCT02932332
High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients
A Phase 2 study testing High-flow Oxygen, Low-flow Oxygen and High-flow Air in people with Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- High-flow Oxygen, Low-flow Oxygen and High-flow Air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2016to 23 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cancer
- Patients seen by palliative care, thoracic oncology, pulmonary medicine, or emergency care at MD Anderson Cancer Center
- Dyspnea Numeric Rating Scale at rest >/=3 of 10 (average over last 24 hour)
- Non-hypoxemic (i.e. oxygen saturation >90% on ambient air)
- Able to communicate in English or Spanish
- Age >/= 18 years
- Able to tolerate high-flow oxygen/air
Who cannot join
- Memorial Delirium Rating Scale >13
- Hemodynamic instability
- Respiratory failure requiring mechanical ventilation or non-invasive ventilation
- Frequent use of rescue opioids >8x/day or rescue bronchodilators >8x/day over last 24 hours
- Currently requiring high flow oxygen for oxygenation
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the detailed description
Study Groups and Procedures:
If you agree to take part in this study, you will receive 4 different breathing therapies:
- High-flow oxygen
- Low-flow oxygen
- High-flow air and
- Low-flow air
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.
- Conditions
- Cancer
- Being tested
- High-flow Oxygen, Low-flow Oxygen, High-flow Air, Low-flow Air
- Keywords
- shortness of breath, oxygen, breathing therapies
- Medical subject headings
- Neoplasms, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flow OxygenOther
Also called HFOx
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%.
Low-flow OxygenOther
Also called LFOx
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 AirOther
Also called HFAir
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 AirOther
Also called LFAir
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: High-flow Oxygen; Other: Low-flow Oxygen; Other: High-flow Air; Other: Low-flow Air |
| 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. Receives: Other: High-flow Oxygen; Other: Low-flow Oxygen; Other: High-flow Air; Other: Low-flow Air |
| 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. Receives: Other: High-flow Oxygen; Other: Low-flow Oxygen; Other: High-flow Air; Other: Low-flow Air |
| Low-flow air: Initial Therapy | Sham comparator | 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. Receives: Other: High-flow Oxygen; Other: Low-flow Oxygen; Other: High-flow Air; Other: Low-flow Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 (baseline) minutes and at 10 minutes
Secondary outcomes (2)
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.
Measured: 0 (baseline) minutes and at 10 minutes
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.
Measured: 0 (baseline) minutes and at 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start11 Oct 2016
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hui, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932332
- Sponsor's protocol ID
- 2016-0282
- Other IDs
- NCI-2017-00186
- Status last verified
- Apr 2023
- First submitted
- 12 Oct 2016
- Last updated
- 21 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 33289276
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients
- ClinicalTrials.gov ID
- NCT02932332
- Acronym / sponsor ID
- 2016-0282
- Conditions
- Cancer
- Keywords
- shortness of breath, oxygen, breathing therapies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 11 Oct 2016 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Posted 20 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Groups and Procedures:
If you agree to take part in this study, you will receive 4 different breathing therapies:
- High-flow oxygen
- Low-flow oxygen
- High-flow air and
- Low-flow air
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High-flow oxygen: Initial Therapy | Active comparator | Other: High-flow Oxygen, Other: Low-flow Oxygen, Other: High-flow Air, Other: Low-flow Air4-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 | Other: High-flow Oxygen, Other: Low-flow Oxygen, Other: High-flow Air, Other: Low-flow Air4-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 | Other: High-flow Oxygen, Other: Low-flow Oxygen, Other: High-flow Air, Other: Low-flow Air4-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 | Sham comparator | Other: High-flow Oxygen, Other: Low-flow Oxygen, Other: High-flow Air, Other: Low-flow Air4-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of cancer
- Patients seen by palliative care, thoracic oncology, pulmonary medicine, or emergency care at MD Anderson Cancer Center
- Dyspnea Numeric Rating Scale at rest >/=3 of 10 (average over last 24 hour)
- Non-hypoxemic (i.e. oxygen saturation >90% on ambient air)
- Able to communicate in English or Spanish
Key exclusion criteria (5 listed)
- Memorial Delirium Rating Scale >13
- Hemodynamic instability
- Respiratory failure requiring mechanical ventilation or non-invasive ventilation
- Frequent use of rescue opioids >8x/day or rescue bronchodilators >8x/day over last 24 hours
- Currently requiring high flow oxygen for oxygenation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-flow OxygenAlso: HFOxOptiflow 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%. | Other | High-flow air: Initial Therapy, High-flow oxygen: Initial Therapy, Low-flow air: Initial Therapy, Low-flow oxygen: Initial Therapy |
| Low-flow OxygenAlso: LFOxLow-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. | Other | High-flow air: Initial Therapy, High-flow oxygen: Initial Therapy, Low-flow air: Initial Therapy, Low-flow oxygen: Initial Therapy |
| High-flow AirAlso: HFAirTwo 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. | Other | High-flow air: Initial Therapy, High-flow oxygen: Initial Therapy, Low-flow air: Initial Therapy, Low-flow oxygen: Initial Therapy |
| Low-flow AirAlso: LFAirTwo 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. | Other | High-flow air: Initial Therapy, High-flow oxygen: Initial Therapy, Low-flow air: Initial Therapy, Low-flow oxygen: Initial Therapy |
Primary outcome
Change in Dyspnea Numeric Score Between 0 and 10 Minutes
Time frame: 0 (baseline) minutes and at 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.
2 secondary outcomes
Change in Modified Borg Scale Intensity Between 0 and 10 Minutes
Time frame: 0 (baseline) minutes and at 10 minutes
Change in Modified Borg Scale Unpleasantness Between 0 and 10 Minutes
Time frame: 0 (baseline) minutes and at 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33289276Hui 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.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hui, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High-flow Oxygen, Low-flow Oxygen and High-flow Air in people with Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dyspnea Numeric Score Between 0 and 10 Minutes (time frame: 0 (baseline) minutes and at 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02932332, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.