Cancer
Conditions
Keywords
shortness of breath, oxygen, breathing therapies
Brief 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.
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.
Interventions
OTHERHigh-flow Oxygen
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%.
OTHERLow-flow Oxygen
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.
OTHERHigh-flow Air
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.
OTHERLow-flow Air
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.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of cancer 2. Patients seen by palliative care, thoracic oncology, pulmonary medicine, or emergency care at MD Anderson Cancer Center 3. Dyspnea Numeric Rating Scale at rest \>/=3 of 10 (average over last 24 hour) 4. Non-hypoxemic (i.e. oxygen saturation \>90% on ambient air) 5. Able to communicate in English or Spanish 6. Age \>/= 18 years 7. Able to tolerate high-flow oxygen/air
Exclusion criteria
1. Memorial Delirium Rating Scale \>13 2. Hemodynamic instability 3. Respiratory failure requiring mechanical ventilation or non-invasive ventilation 4. Frequent use of rescue opioids \>8x/day or rescue bronchodilators \>8x/day over last 24 hours 5. Currently requiring high flow oxygen for oxygenation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dyspnea Numeric Score Between 0 and 10 Minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Borg Scale Intensity Between 0 and 10 Minutes | 0 (baseline) minutes and at 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. |
| Change in Modified Borg Scale Unpleasantness Between 0 and 10 Minutes | 0 (baseline) minutes and at 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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)
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| 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 | 4 |
| 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 | 5 |
| 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 | 5 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Chest pain | 0 | 0 | 0 | 1 |
| Overall Study | Not Dyspneic cough | 1 | 2 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir) | Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx) | Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir) | Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx) |
|---|---|---|---|---|---|
| Age, Continuous | 51 years | 51 years | 50 years | 48 years | 55 years |
| Cancer Stage II | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Cancer Stage III | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Cancer Stage IV | 17 Participants | 4 Participants | 4 Participants | 4 Participants | 5 Participants |
| Cancer Type Breast | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Cancer Type Gastrointestinal | 7 Participants | 2 Participants | 1 Participants | 1 Participants | 3 Participants |
| Cancer Type Genitourinary | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Cancer Type Gynecological | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Cancer Type Hematologic | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Cancer Type Other | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Cancer Type Thoracic | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants |
| Dyspnea for reason of admission No | 10 Participants | 3 Participants | 1 Participants | 3 Participants | 3 Participants |
| Dyspnea for reason of admission Yes | 9 Participants | 2 Participants | 4 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 4 Participants | 4 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 5 Participants | 3 Participants | 3 Participants | 4 Participants |
| Region of Enrollment United States | 19 participants | 5 participants | 5 participants | 4 participants | 5 participants |
| Sex: Female, Male Female | 11 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 8 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants |
| Supplement Oxygen No | 10 Participants | 3 Participants | 2 Participants | 3 Participants | 2 Participants |
| Supplement Oxygen Yes | 9 Participants | 2 Participants | 3 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 13 | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 7 / 12 | 6 / 13 | 4 / 13 | 7 / 13 |
| serious Total, serious adverse events | 0 / 12 | 0 / 13 | 0 / 13 | 0 / 13 |
Outcome results
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.
Time frame: 0 (baseline) minutes and at 10 minutes
Population: Participants who completed the first intervention.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx) | Change in Dyspnea Numeric Score Between 0 and 10 Minutes | -1.8 score on a scale |
| Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir) | Change in Dyspnea Numeric Score Between 0 and 10 Minutes | -1.8 score on a scale |
| Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx) | Change in Dyspnea Numeric Score Between 0 and 10 Minutes | -0.6 score on a scale |
| Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir) | Change in Dyspnea Numeric Score Between 0 and 10 Minutes | -0.5 score on a scale |
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.
Time frame: 0 (baseline) minutes and at 10 minutes
Population: Participants who completed the first intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx) | Change in Modified Borg Scale Intensity Between 0 and 10 Minutes | -0.7 score on a scale |
| Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir) | Change in Modified Borg Scale Intensity Between 0 and 10 Minutes | -1.8 score on a scale |
| Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx) | Change in Modified Borg Scale Intensity Between 0 and 10 Minutes | -0.1 score on a scale |
| Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir) | Change in Modified Borg Scale Intensity Between 0 and 10 Minutes | -0.5 score on a scale |
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.
Time frame: 0 (baseline) minutes and at 10 minutes
Population: Participants who completed the first intervention.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx) | Change in Modified Borg Scale Unpleasantness Between 0 and 10 Minutes | -0.5 score on a scale |
| Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir) | Change in Modified Borg Scale Unpleasantness Between 0 and 10 Minutes | -1.8 score on a scale |
| Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx) | Change in Modified Borg Scale Unpleasantness Between 0 and 10 Minutes | -0.6 score on a scale |
| Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir) | Change in Modified Borg Scale Unpleasantness Between 0 and 10 Minutes | -0.7 score on a scale |