Skip to main content
OpenTrials
Completed

NCT Number: NCT02932332

High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-flow Oxygen

Other

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%.

Other names: HFOx

Low-flow Oxygen

Other

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.

Other names: LFOx

High-flow Air

Other

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.

Other names: HFAir

Low-flow Air

Other

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.

Other names: LFAir

Primary outcomes

  1. Change in Dyspnea Numeric Score Between 0 and 10 Minutes

    Time frame: 0 (baseline) minutes and at 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.

Secondary outcomes

  1. Change in Modified Borg Scale Intensity Between 0 and 10 Minutes

    Time frame: 0 (baseline) minutes and at 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.

  2. Change in Modified Borg Scale Unpleasantness Between 0 and 10 Minutes

    Time frame: 0 (baseline) minutes and at 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2016
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.