search
Back to results

High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients

Primary Purpose

Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
High-flow Oxygen
Low-flow Oxygen
High-flow Air
Low-flow Air
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring shortness of breath, oxygen, breathing therapies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Sham Comparator

Arm Label

High-flow oxygen: Initial Therapy

Low-flow oxygen: Initial Therapy

High-flow air: Initial Therapy

Low-flow air: Initial Therapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 12, 2016
Last Updated
April 20, 2023
Sponsor
M.D. Anderson Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02932332
Brief Title
High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients
Official Title
High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 11, 2016 (Actual)
Primary Completion Date
March 23, 2023 (Actual)
Study Completion Date
March 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
shortness of breath, oxygen, breathing therapies

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-flow oxygen: Initial Therapy
Arm Type
Active Comparator
Arm 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.
Arm Title
Low-flow oxygen: Initial Therapy
Arm Type
Active Comparator
Arm 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.
Arm Title
High-flow air: Initial Therapy
Arm Type
Sham Comparator
Arm 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.
Arm Title
Low-flow air: Initial Therapy
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
High-flow Oxygen
Other Intervention Name(s)
HFOx
Intervention Description
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%.
Intervention Type
Other
Intervention Name(s)
Low-flow Oxygen
Other Intervention Name(s)
LFOx
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
High-flow Air
Other Intervention Name(s)
HFAir
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Low-flow Air
Other Intervention Name(s)
LFAir
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Dyspnea Numeric Score Between 0 and 10 Minutes
Description
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.
Time Frame
0 (baseline) minutes and at 10 minutes
Secondary Outcome Measure Information:
Title
Change in Modified Borg Scale Intensity Between 0 and 10 Minutes
Description
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.
Time Frame
0 (baseline) minutes and at 10 minutes
Title
Change in Modified Borg Scale Unpleasantness Between 0 and 10 Minutes
Description
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.
Time Frame
0 (baseline) minutes and at 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hui, MD
Organizational Affiliation
The University of Texas MD Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33289276
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.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients

We'll reach out to this number within 24 hrs