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

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ClinicalTrials.gov Identifier: NCT02357134
Recruitment Status : Active, not recruiting
First Posted : February 6, 2015
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Dyspnea Malignant Neoplasm Procedure: Oxygen Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration Procedure: Respiratory Therapy Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

I. 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: High-Flow Oxygen for Exertional Dyspnea in Cancer Patients
Actual Study Start Date : March 17, 2015
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (high-flow oxygen)
Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.
Procedure: Oxygen Therapy
Receive high-flow oxygen
Other Name: supplemental oxygen therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm II (high-flow air)
Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session
Procedure: Oxygen Therapy
Receive high-flow air
Other Name: supplemental oxygen therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Arm III (low-flow oxygen)
Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Procedure: Respiratory Therapy
Receive low-flow oxygen

Active Comparator: Arm IV (low-flow air)
Patients receive low-flow air via a nasal cannula during a structured stationary bicycle exercise session.
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Procedure: Respiratory Therapy
Receive low-flow air




Primary Outcome Measures :
  1. Dyspnea Borg score [ Time Frame: At isotime (baseline) ]

    Dyspnea Borg score is a 0 to 10 categorical scale for rating the severity of dyspnea by the patient.

    Scale ranges from 0 meaning "Nothing at All" to 10 meaning "Very Very Severe".



Secondary Outcome Measures :
  1. Changes in Cancer Dyspnea score [ Time Frame: Baseline to day 3 ]
    Cancer Dyspnea score ranges from 1 meaning "Not at All" to 5 meaning "Very Much".

  2. Proportion of patients who complete the study [ Time Frame: Day 3 (at the end of second session) ]
    Analysis will include an appropriate 95% confidence interval.

  3. Effects of Oxygen and Flow Rate on Physiologic Function [ Time Frame: Baseline to day 3 (during structured exercise) ]
    The effect of the flow rate (i.e., the adjusted mean difference between high and low flow) can be calculated as b1 for ambient air and b1 + b3 for oxygen. Similarly, the effect of oxygen can be calculated as b2 for low flow and b2 + b3 for high flow.

  4. Change in exercise capacity [ Time Frame: Baseline to day 3 (during structured exercise) ]
    To measure the effects of oxygen and flow rate on exercise capacity, mixed-effects linear models will be used.

  5. Incidence of adverse events [ Time Frame: Up to day 3 (after intervention) ]
    Adverse events will be assessed using a numeric rating scale from 0 to 10 before and after intervention. Differences in these scores for each type of adverse event will be analyzed using general linear models.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357134


Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: David Hui M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02357134     History of Changes
Other Study ID Numbers: 2014-0971
NCI-2015-00418 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2014-0971 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms
Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms