High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients

Conditions
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Cancer

Intervention / Treatment
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* Other: High-flow Oxygen
* Other: Low-flow Oxygen
* Other: High-flow Air
* Other: Low-flow Air


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High-flow oxygen: Initial Therapy<br>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. | Other: High-flow Oxygen<br>* 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%.<br>* Other names: HFOx;Other: Low-flow Oxygen<br>* 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.<br>* Other names: LFOx;Other: High-flow Air<br>* 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.<br>* Other names: HFAir;Other: Low-flow Air<br>* 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.<br>* Other names: LFAir;|
| Active Comparator: Low-flow oxygen: Initial Therapy<br>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. | Other: High-flow Oxygen<br>* 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%.<br>* Other names: HFOx;Other: Low-flow Oxygen<br>* 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.<br>* Other names: LFOx;Other: High-flow Air<br>* 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.<br>* Other names: HFAir;Other: Low-flow Air<br>* 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.<br>* Other names: LFAir;|
| Sham Comparator: High-flow air: Initial Therapy<br>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. | Other: High-flow Oxygen<br>* 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%.<br>* Other names: HFOx;Other: Low-flow Oxygen<br>* 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.<br>* Other names: LFOx;Other: High-flow Air<br>* 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.<br>* Other names: HFAir;Other: Low-flow Air<br>* 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.<br>* Other names: LFAir;|
| Sham Comparator: Low-flow air: Initial Therapy<br>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. | Other: High-flow Oxygen<br>* 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%.<br>* Other names: HFOx;Other: Low-flow Oxygen<br>* 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.<br>* Other names: LFOx;Other: High-flow Air<br>* 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.<br>* Other names: HFAir;Other: Low-flow Air<br>* 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.<br>* Other names: LFAir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shortness of breath, oxygen, breathing therapies