High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02932332
Collaborator
(none)
26
1
4
72.6
0.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: High-flow Oxygen
  • Other: Low-flow Oxygen
  • Other: High-flow Air
  • Other: Low-flow Air
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients
Actual Study Start Date :
Oct 11, 2016
Anticipated Primary Completion Date :
Oct 31, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: High-flow oxygen: Initial Therapy

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.

Other: High-flow Oxygen
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
  • Other: Low-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.
    Other Names:
  • LFOx
  • Other: High-flow Air
    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
  • Other: Low-flow Air
    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
  • Active Comparator: Low-flow oxygen: Initial Therapy

    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.

    Other: High-flow Oxygen
    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
  • Other: Low-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.
    Other Names:
  • LFOx
  • Other: High-flow Air
    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
  • Other: Low-flow Air
    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
  • Sham Comparator: High-flow air: Initial Therapy

    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.

    Other: High-flow Oxygen
    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
  • Other: Low-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.
    Other Names:
  • LFOx
  • Other: High-flow Air
    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
  • Other: Low-flow Air
    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
  • Sham Comparator: Low-flow air: Initial Therapy

    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.

    Other: High-flow Oxygen
    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
  • Other: Low-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.
    Other Names:
  • LFOx
  • Other: High-flow Air
    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
  • Other: Low-flow Air
    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
  • Outcome Measures

    Primary Outcome Measures

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Texas MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Study Chair: David Hui, MD, The University of Texas MD Anderson Cancer Center

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02932332
    Other Study ID Numbers:
    • 2016-0282
    • NCI-2017-00186
    First Posted:
    Oct 13, 2016
    Last Update Posted:
    Apr 19, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by M.D. Anderson Cancer Center
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Patients were recruited from MD Anderson Cancer Center with active cancer diagnosis , having age >=18, an average dyspnea numeric rating scale of ≥4/10 over the past 24 hours, oxygen saturation >90% on ambient air and able to tolerate high flow nasal canula.
    Pre-assignment Detail A total of 26 participants were consented but 19 patients were randomized for this study. 7 patients were not randomized for various reasons (discharged too early=3, changed mind=2 and others =2)
    Arm/Group Title 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)
    Arm/Group Description 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 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 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 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
    Period Title: Overall Study
    STARTED 5 4 5 5
    Intervention 1 4 4 5 4
    Intervention 2 4 3 4 4
    Intervention 3 3 2 4 3
    Intervention 4 3 1 4 3
    COMPLETED 3 1 4 3
    NOT COMPLETED 2 3 1 2

    Baseline Characteristics

    Arm/Group Title 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
    Arm/Group Description 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 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 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 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 Total of all reporting groups
    Overall Participants 5 4 5 5 19
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    55
    48
    50
    51
    51
    Sex: Female, Male (Count of Participants)
    Female
    2
    40%
    3
    75%
    3
    60%
    3
    60%
    11
    57.9%
    Male
    3
    60%
    1
    25%
    2
    40%
    2
    40%
    8
    42.1%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    1
    20%
    1
    20%
    2
    10.5%
    Not Hispanic or Latino
    5
    100%
    4
    100%
    4
    80%
    4
    80%
    17
    89.5%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    1
    20%
    1
    25%
    2
    40%
    0
    0%
    4
    21.1%
    White
    4
    80%
    3
    75%
    3
    60%
    5
    100%
    15
    78.9%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    5
    100%
    4
    100%
    5
    100%
    5
    100%
    19
    100%
    Cancer Stage (Count of Participants)
    II
    0
    0%
    0
    0%
    0
    0%
    1
    20%
    1
    5.3%
    III
    0
    0%
    0
    0%
    1
    20%
    0
    0%
    1
    5.3%
    IV
    5
    100%
    4
    100%
    4
    80%
    4
    80%
    17
    89.5%
    Cancer Type (Count of Participants)
    Breast
    0
    0%
    0
    0%
    1
    20%
    1
    20%
    2
    10.5%
    Gastrointestinal
    3
    60%
    1
    25%
    1
    20%
    2
    40%
    7
    36.8%
    Genitourinary
    0
    0%
    1
    25%
    1
    20%
    0
    0%
    2
    10.5%
    Gynecological
    0
    0%
    0
    0%
    1
    20%
    0
    0%
    1
    5.3%
    Hematologic
    0
    0%
    1
    25%
    0
    0%
    1
    20%
    2
    10.5%
    Thoracic
    1
    20%
    1
    25%
    1
    20%
    1
    20%
    4
    21.1%
    Other
    1
    20%
    0
    0%
    0
    0%
    0
    0%
    1
    5.3%
    Dyspnea for reason of admission (Count of Participants)
    Yes
    2
    40%
    1
    25%
    4
    80%
    2
    40%
    9
    47.4%
    No
    3
    60%
    3
    75%
    1
    20%
    3
    60%
    10
    52.6%
    Supplement Oxygen (Count of Participants)
    Yes
    3
    60%
    1
    25%
    3
    60%
    2
    40%
    9
    47.4%
    No
    2
    40%
    3
    75%
    2
    40%
    3
    60%
    10
    52.6%

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants who completed the first intervention.
    Arm/Group Title 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)
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 4 4 5 4
    Mean (95% Confidence Interval) [score on a scale]
    -1.8
    -1.8
    -0.6
    -0.5
    2. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants who completed the first intervention
    Arm/Group Title 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)
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 4 4 5 4
    Mean (95% Confidence Interval) [score on a scale]
    -0.7
    -1.8
    -0.1
    -0.5
    3. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants who completed the first intervention.
    Arm/Group Title 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)
    Arm/Group Description 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. 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. 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. 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.
    Measure Participants 4 4 5 4
    Mean (95% Confidence Interval) [score on a scale]
    -0.5
    -1.8
    -0.6
    -0.7

    Adverse Events

    Time Frame baseline and 10 minutes of each intervention.
    Adverse Event Reporting Description 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.
    Arm/Group Title High Flow Air High Flow Oxygen Low Flow Air Low Flow Oxygen
    Arm/Group Description High Flow Air was delivered between 20 and 60 L/min. High Flow Oxygen was delivered between 20 and 60 L/min. Low Flow Air was delivered at 2L/min. Low Flow Oxygen was delivered at 2L/min.
    All Cause Mortality
    High Flow Air High Flow Oxygen Low Flow Air Low Flow Oxygen
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/12 (0%) 0/13 (0%) 0/13 (0%) 0/13 (0%)
    Serious Adverse Events
    High Flow Air High Flow Oxygen Low Flow Air Low Flow Oxygen
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/12 (0%) 0/13 (0%) 0/13 (0%) 0/13 (0%)
    Other (Not Including Serious) Adverse Events
    High Flow Air High Flow Oxygen Low Flow Air Low Flow Oxygen
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/12 (58.3%) 6/13 (46.2%) 4/13 (30.8%) 7/13 (53.8%)
    Nervous system disorders
    Anxiety 4/12 (33.3%) 3/13 (23.1%) 4/13 (30.8%) 1/13 (7.7%)
    Dry eyes 1/12 (8.3%) 2/13 (15.4%) 1/13 (7.7%) 1/13 (7.7%)
    Eye irritation 0/12 (0%) 2/13 (15.4%) 2/13 (15.4%) 0/13 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dry Nose 2/12 (16.7%) 4/13 (30.8%) 2/13 (15.4%) 7/13 (53.8%)
    Moisture in nose 7/12 (58.3%) 6/13 (46.2%) 2/13 (15.4%) 5/13 (38.5%)
    Nasal prong uncomfortable 5/12 (41.7%) 5/13 (38.5%) 3/13 (23.1%) 5/13 (38.5%)
    Feeling of suffocation 4/12 (33.3%) 2/13 (15.4%) 2/13 (15.4%) 0/13 (0%)
    Trouble talking 3/12 (25%) 2/13 (15.4%) 4/13 (30.8%) 2/13 (15.4%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title David Hui, MD, Associate Professor/Palliative Care Med
    Organization UT MD Anderson Cancer Center
    Phone 713-792-6258
    Email dhui@mdanderson.org
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02932332
    Other Study ID Numbers:
    • 2016-0282
    • NCI-2017-00186
    First Posted:
    Oct 13, 2016
    Last Update Posted:
    Apr 19, 2022
    Last Verified:
    Mar 1, 2022