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DyspneaPhase 2NCT02357134

High-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer

A Phase 2 study testing Oxygen Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Dyspnea and Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This randomized phase II trial studies how well high-flow oxygen works in reducing difficulty breathing during exercise (exertional dyspnea) in patients with cancer. Dyspnea is linked to decreased lung function, quality of life, and survival. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dyspnea, Malignant Neoplasm
What is being tested?
Oxygen Therapy, Quality-of-Life Assessment and Questionnaire Administration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteUnited States
Study dates
17 Mar 2015to 31 May 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of cancer, with evidence of primary or secondary lung involvement
  • Average dyspnea Borg Scale >= 4 of 10 with severe exertion over the past week
  • Oxygen saturation > 90% on ambient air at time of assessment
  • Able to communicate in English or Spanish
  • Karnofsky performance status >= 50%
  • Seen at Supportive Care, cardiopulmonary center, thoracic radiation oncology or thoracic medical oncology

Who cannot join

  • Resting dyspnea modified Borg Scale > 7 of 10 at enrollment
  • Severe obstructive lung disease (forced expiratory volume in 1 second [FEV1]/forced vital capacity [FVC] < 70% post bronchodilator and forced expiratory volume in 1 second < 30% predicted)
  • Delirium (i.e., Memorial Delirium Rating Scale > 13)
  • History of unstable angina or myocardial infarction in the last week
  • Acute pulmonary embolus or pulmonary infarction in the last week
  • Thrombosis of lower extremities in the last week
Show all 15Show fewer
  • Acute myocarditis, pericarditis, or endocarditis in the last week
  • Symptomatic aortic stenosis or syncope in the last week
  • Suspected dissecting aneurysm
  • Severe untreated resting arterial hypertension (> 200 mmHg systolic, > 120 mmHg diastolic) at the time of enrollment
  • Uncontrolled arrhythmias causing symptoms or hemodynamic compromise in the last week
  • Uncontrolled heart failure in the last week
  • Pleural effusion requiring thoracentesis within 1 week of study enrollment or scheduled during the study period
  • Airway obstruction requiring stenting within 1 week of study enrollment or scheduled during the study period
  • Pneumonia requiring antibiotics at the time of study enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: High-Flow Oxygen for Exertional Dyspnea in Cancer Patients

This randomized phase II trial studies how well high-flow oxygen works in reducing difficulty breathing during exercise (exertional dyspnea) in patients with cancer. Dyspnea is linked to decreased lung function, quality of life, and survival. High-flow oxygen is a device that delivers heated and humidified oxygen through the nose. This may be effective in reducing dyspnea, and may help patients' lungs function better and improve their quality of life.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Obtain preliminary estimates of the effect size of oxygen and high flow rate on exertional dyspnea (modified Borg Scale adjusted for work rate and baseline dyspnea).

SECONDARY OBJECTIVES:

  1. Determine the completion rate of a randomized controlled trial of exertional dyspnea in cancer patients.

II. Obtain preliminary estimates of the effects of oxygen and flow rate on physiologic function (respiratory rate and oxygen saturation) and exercise capacity (work rate and exercise duration).

OUTLINE: All patients undergo a baseline structured exercise session with air. Patients are then randomized to 1 of 4 treatments for a second session approximately 3 days later.

ARM I: Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.

ARM II: Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session.

ARM III: Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.

ARM IV: Patients receive low-flow air via a nasal cannula during structured stationary bicycle exercise session.

Being tested
Oxygen Therapy, Quality-of-Life Assessment, Questionnaire Administration, Respiratory Therapy
Medical subject headings
Dyspnea, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxygen TherapyProcedure or surgery

    Also called supplemental oxygen therapy

    Receive high-flow oxygen

  • Oxygen TherapyProcedure or surgery

    Also called supplemental oxygen therapy

    Receive high-flow air

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Respiratory TherapyProcedure or surgery

    Receive low-flow oxygen

  • Respiratory TherapyProcedure or surgery

    Receive low-flow air

Study groups in NCT02357134
Study groupRoleWhat they receive
Arm I (high-flow oxygen)ExperimentalPatients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.
Receives: Procedure: Oxygen Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm II (high-flow air)ExperimentalPatients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session
Receives: Procedure: Oxygen Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm III (low-flow oxygen)Active comparatorPatients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.
Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Respiratory Therapy
Arm IV (low-flow air)Active comparatorPatients receive low-flow air via a nasal cannula during a structured stationary bicycle exercise session.
Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Respiratory Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Borg Scale Dyspnea Intensity at Isotime

    Assessed Dyspnea using the Modified Borg Scale Dyspnea Intensity that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath") at Isotime. Measured the mean difference of Modified Borg Scale Dyspnea Intensity at isotime between the second exercise test (in which all patients received Low Flow Oxygen) and the third exercise tests (in which all patients received the assigned intervention).

    Measured: End of second exercise test and end of third exercise test, approximately up to 12 minutes

Secondary outcomes (4)

  1. Slope of Modified Borg Scale Dyspnea Unpleasantness Over Time During Constant Work Exercise Per Minute (Third Test)

    Dyspnea unpleasantness was measured using the Modified Borg Scale Dyspnea Intensity that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Dyspnea intensity was measured every minute. The number of minutes varied by patient, per test. It was measured as pairwise difference of slope (taking 'low flow air' arm as a reference). This linear mixed model was constructed based on the following: Dyspnea Unpleasantness at third test = Minutes + Study Arm + Study Arm*Minutes + Total work rate + Slope of Dyspnea Unpleasantness and Minutes at Second test + Minutes at second test.

    Measured: Third exercise test, approximately up to 12 minutes

  2. Modified Borg Scale Leg Discomfort

    Leg discomfort was measured using the Modified Borg Scale Leg discomfort that ranges from 0 ("no discomfort") to 10 ("worst possible discomfort") during the constant work exercise of third test. Leg discomfort was measured every minute. The number of minutes varied by patient, per test. It was measured as pairwise difference of slope (taking 'low flow air' arm as a reference). This linear mixed model was constructed based on the following: Leg Discomfort at third test = Minutes + Study Arm + Study Arm*Minutes + Total work rate + Slope of Leg Discomfort and Minutes at Second test + Minutes at Second test.

    Measured: Third exercise test, approximately up to 12 minutes

  3. Exercise Endurance

    The Exercise endurance was measured as a mean duration of constant work in minutes during third test. It was measured as pairwise comparison of mean difference of exercise duration (taking 'low flow air' as a reference). This linear mixed model was constructed based on the following: Time at third test = Study Arm + Minutes at Second test. Detail output from the mixed models

    Measured: End of third exercise test, approximately up to 12 minutes

  4. Adverse Events

    Adverse effects related to supplemental oxygen use were assessed using a numeric rating scale from 0 (not at all) to 10 (worst possible) before and after the study intervention. The mean change was measured before and after the 3rd test ranging between -10 (improvement) and +10 (deterioration).

    Measured: Before and after 3rd test during intervention phase, approximately up to 12 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2015 (estimated)
  2. Study start17 Mar 2015
  3. Primary completion30 Dec 2020
  4. Study completion31 May 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02357134
Sponsor's protocol ID
2014-0971
Other IDs
NCI-2015-00418, 2014-0971
Status last verified
Nov 2022
First submitted
29 Jan 2015
Last updated
7 Dec 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hui D, Mahler DA, Larsson L, Wu J, Thomas S, Harrison CA, Hess K, Lopez-Mattei J, Thompson K, Gomez D, Jeter M, Lin S, Basen-Engquist K, Bruera E. High-Flow Nasal Cannula Therapy for Exertional Dyspnea in Patients with Cancer: A Pilot Randomized Clinical Trial. Oncologist. 2021 Aug;26(8):e1470-e1479. doi: 10.1002/onco.13624. Epub 2020 Dec 14.

    PubMed 33289280

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxygen Therapy, Quality-of-Life Assessment and Questionnaire Administration in people with Dyspnea and Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Borg Scale Dyspnea Intensity at Isotime (time frame: End of second exercise test and end of third exercise test, approximately up to 12 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02357134, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.

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