Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

All Conditions

Dyspnea

Respiratory Aspiration

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

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.

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.

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.

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.

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%.

High-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.

Low-flow Oxygen

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.

High-flow Air

Low-flow Air

David Hui, MD

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.

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.

High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients

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.

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.

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.

M.D. Anderson Cancer Center

Adverse effects such as dry eyes, dry nose, nasal moisture and anxiety were assessed using a 0-10 numeric rating scale, where 0=none and 10=worst possible. The participants 'at risk' are a total number of participants combined that received specific intervention from each group at different sequences.

High Flow Air was delivered between 20 and 60 L/min.

High Flow Air

High Flow Oxygen was delivered between 20 and 60 L/min.

High Flow Oxygen

Low Flow Air

Low Flow Oxygen

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

Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx)

Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir)

Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx)

Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Cancer is typically labeled in stages from I to IV, with IV being the most serious.

Cancer Stage

Breast

Gastrointestinal

Genitourinary

Gynecological

Hematologic

Thoracic

Other

Cancer Type

Dyspnea for reason of admission

Supplement Oxygen

David Hui, MD, Associate Professor/Palliative Care Med

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.

Spots Global Cancer Trial Database for breathing therapies