Clinical trial NCT02932332: High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients
Official title: High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Keywords: shortness of breath
oxygen
breathing therapies
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Dyspnea Numeric Score Between 0 and 10 Minutes
timeFrame: 0 (baseline) minutes and at 10 minutes
Secondary outcomes:
measure: Change in Modified Borg Scale Intensity Between 0 and 10 Minutes
timeFrame: 0 (baseline) minutes and at 10 minutes
measure: Change in Modified Borg Scale Unpleasantness Between 0 and 10 Minutes
timeFrame: 0 (baseline) minutes and at 10 minutes
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: The University of Texas MD Anderson Cancer Center
name: David Hui, MD
role: STUDY_CHAIR
References:
citation: 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.