High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients
2 other identifiers
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 cancer
Started Oct 2016
Longer than P75 for phase_2 cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2016
CompletedFirst Submitted
Initial submission to the registry
October 12, 2016
CompletedFirst Posted
Study publicly available on registry
October 13, 2016
CompletedResults Posted
Study results publicly available
September 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2023
CompletedApril 21, 2023
April 1, 2023
6.4 years
October 12, 2016
July 20, 2021
April 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change in Modified Borg Scale Intensity Between 0 and 10 Minutes
0 (baseline) minutes and at 10 minutes
Change in Modified Borg Scale Unpleasantness Between 0 and 10 Minutes
0 (baseline) minutes and at 10 minutes
Study Arms (4)
High-flow oxygen: Initial Therapy
ACTIVE COMPARATOR4-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.
Low-flow oxygen: Initial Therapy
ACTIVE COMPARATOR4-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.
High-flow air: Initial Therapy
SHAM COMPARATOR4-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.
Low-flow air: Initial Therapy
SHAM COMPARATOR4-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.
Interventions
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 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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
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.
PMID: 33289276DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Hui, MD, Associate Professor/Palliative Care Med
- Organization
- UT MD Anderson Cancer Center
Study Officials
- STUDY CHAIR
David Hui, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2016
First Posted
October 13, 2016
Study Start
October 11, 2016
Primary Completion
March 23, 2023
Study Completion
March 23, 2023
Last Updated
April 21, 2023
Results First Posted
September 20, 2021
Record last verified: 2023-04