High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients

Cancer Clinical Trial

Official title:

High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932332
• Other study ID #: 2016-0282
• Secondary ID: NCI-2017-00186
• Status: Completed
• Phase: Phase 2
• Start date: October 11, 2016
• Est. completion date: March 23, 2023

Study information

• Verified date: April 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Dyspnea

Intervention

Other:
• High-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%.
• Low-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.
• High-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.
• Low-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.

Locations

Country	Name	City	State
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	0 (baseline) minutes and at 10 minutes
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.	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.	0 (baseline) minutes and at 10 minutes

External Links

•   MD Anderson Cancer Center