High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 2

Conditions: Cancer

Treatments: Other: Low-flow Oxygen; Other: High-flow Air; Other: Low-flow Air; Other: High-flow Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT02932332

2016-0282

NCI-2017-00186 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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26 participants in 4 patient groups

High-flow oxygen: Initial Therapy

Active Comparator group

Description:

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.

Treatment:

Other: High-flow Oxygen

Other: Low-flow Air

Other: High-flow Air

Other: Low-flow Oxygen

Low-flow oxygen: Initial Therapy

Active Comparator group

Description:

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.

Treatment:

Other: High-flow Oxygen

Other: Low-flow Air

Other: High-flow Air

Other: Low-flow Oxygen

High-flow air: Initial Therapy

Sham Comparator group

Description:

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.

Treatment:

Other: High-flow Oxygen

Other: Low-flow Air

Other: High-flow Air

Other: Low-flow Oxygen

Low-flow air: Initial Therapy

Sham Comparator group

Description:

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.

Treatment:

Other: High-flow Oxygen

Other: Low-flow Air

Other: High-flow Air

Other: Low-flow Oxygen