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High-Flow Oxygen for Exertional Dyspnea in Cancer Patients

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ClinicalTrials.gov Identifier: NCT02357134
Recruitment Status : Active, not recruiting
First Posted : February 6, 2015
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to learn if high-flow oxygen, low-flow oxygen, high-flow air, or low-flow air, when given during structured exercise sessions, can help reduce difficulty breathing 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
Advanced Cancers Other: Stationary Bicycle Test Behavioral: Questionnaires Other: Structured Exercise with High Flow Oxygen Other: Structured Exercise with High Flow Air Other: Structured Exercise with Low Flow Oxygen Other: Structured Exercise with Low Flow Air Phase 2

Detailed Description:

Study Groups:

If you are found to be eligible to take part in this study, about 3 days after you complete the baseline cycle tests (described below), you will be randomly assigned (as in a roll of dice) to receive 1 of the following 4 treatments during a second cycle test. Your study group assignment will also be based on your breathing symptoms at screening.

  • High-flow oxygen
  • Low-flow oxygen
  • High-flow air
  • Low-flow air

You will have an equal chance of being assigned to each group. Neither you nor the study staff will know which treatment you are assigned to. However, if needed for your safety, the study staff will be able to find out what you are receiving.

Study Visits:

Baseline Cycle Tests:

At a time that is convenient for you after screening, you will perform a cycle test using a stationary bicycle. You will pedal with no resistance for 60 seconds, then you will warm up for 2 minutes. You will perform the cycle test while receiving low-flow air for as long as you can.

Every 2 minutes during the cycle test your blood pressure, heart rate, and blood oxygen levels will be checked.

After a 2-hour rest, you will perform the cycle test again using low-flow air for as long as you can.

Before each cycle test, you will have an electrocardiogram (EKG) to check your heart function.

Second Cycle Test:

About 3 days after the baseline cycle test (± 2 days), you will take part in a second cycle test. Before this test, you will have an EKG. During the test, you will receive the type of study treatment you were assigned to after your screening tests.

After the cycle test, you will fill out the same questionnaires you completed at screening.

Length of Study:

You may be taken off study if you have problems completing either cycle test. Your participation on the study will be over when you have completed the second cycle test and filled out the questionnaires.

This is an investigational study. The use of high-flow air, low-flow air, high-flow oxygen, or low-flow oxygen during exercise to treat breathing symptoms is considered investigational.

Up to 50 patients will be enrolled in this study. All will be enrolled at MD Anderson.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: High-Flow Oxygen for Exertional Dyspnea in Cancer Patients
Actual Study Start Date : March 17, 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Structured Exercise with High Flow Oxygen

After screening, participants perform a cycle test using a stationary bicycle. Participants pedal with no resistance for 60 seconds. Participants perform the cycle test without receiving any air or oxygen for as long as they can. After a 2 hour rest, participant performs the cycle test again using low-flow air for as long as they can.

About 3 days after baseline cycle test, second cycle test performed using high flow oxygen.

Four symptom questionnaires completed at screening and after the second cycle test. This should take about 40 minutes to complete.

Other: Stationary Bicycle Test
All groups: After screening, participants perform a cycle test using a stationary bicycle. Participants pedal with no resistance for 60 seconds. Participants perform the cycle test without receiving any air or oxygen for as long as they can. After a 2 hour rest, participant performs the cycle test again using low-flow air for as long as they can.

Behavioral: Questionnaires
Four symptom questionnaires completed at screening and after the second cycle test. This should take about 40 minutes to complete.
Other Name: Surveys

Other: Structured Exercise with High Flow Oxygen
About 3 days after baseline cycle test, second cycle test performed using high flow oxygen.

Experimental: Structured Exercise with High Flow Air

After screening, participants perform a cycle test using a stationary bicycle. Participants pedal with no resistance for 60 seconds. Participants perform the cycle test without receiving any air or oxygen for as long as they can. After a 2 hour rest, participant performs the cycle test again using low-flow air for as long as they can.

About 3 days after baseline cycle test, second cycle test performed using high flow air.

Four symptom questionnaires completed at screening and after the second cycle test. This should take about 40 minutes to complete.

Other: Stationary Bicycle Test
All groups: After screening, participants perform a cycle test using a stationary bicycle. Participants pedal with no resistance for 60 seconds. Participants perform the cycle test without receiving any air or oxygen for as long as they can. After a 2 hour rest, participant performs the cycle test again using low-flow air for as long as they can.

Behavioral: Questionnaires
Four symptom questionnaires completed at screening and after the second cycle test. This should take about 40 minutes to complete.
Other Name: Surveys

Other: Structured Exercise with High Flow Air
About 3 days after baseline cycle test, second cycle test performed using high flow air.

Experimental: Structured Exercise with Low Flow Oxygen

After screening, participants perform a cycle test using a stationary bicycle. Participants pedal with no resistance for 60 seconds. Participants perform the cycle test without receiving any air or oxygen for as long as they can. After a 2 hour rest, participant performs the cycle test again using low-flow air for as long as they can.

About 3 days after baseline cycle test, second cycle test performed using low flow oxygen.

Four symptom questionnaires completed at screening and after the second cycle test. This should take about 40 minutes to complete.

Other: Stationary Bicycle Test
All groups: After screening, participants perform a cycle test using a stationary bicycle. Participants pedal with no resistance for 60 seconds. Participants perform the cycle test without receiving any air or oxygen for as long as they can. After a 2 hour rest, participant performs the cycle test again using low-flow air for as long as they can.

Behavioral: Questionnaires
Four symptom questionnaires completed at screening and after the second cycle test. This should take about 40 minutes to complete.
Other Name: Surveys

Other: Structured Exercise with Low Flow Oxygen
About 3 days after baseline cycle test, second cycle test performed using low flow oxygen.

Experimental: Structured Exercise with Low Flow Air

After screening, participants perform a cycle test using a stationary bicycle. Participants pedal with no resistance for 60 seconds. Participants perform the cycle test without receiving any air or oxygen for as long as they can. After a 2 hour rest, participant performs the cycle test again using low-flow air for as long as they can.

About 3 days after baseline cycle test, second cycle test performed using low flow air.

Four symptom questionnaires completed at screening and after the second cycle test. This should take about 40 minutes to complete.

Other: Stationary Bicycle Test
All groups: After screening, participants perform a cycle test using a stationary bicycle. Participants pedal with no resistance for 60 seconds. Participants perform the cycle test without receiving any air or oxygen for as long as they can. After a 2 hour rest, participant performs the cycle test again using low-flow air for as long as they can.

Behavioral: Questionnaires
Four symptom questionnaires completed at screening and after the second cycle test. This should take about 40 minutes to complete.
Other Name: Surveys

Other: Structured Exercise with Low Flow Air
About 3 days after baseline cycle test, second cycle test performed using low flow air.




Primary Outcome Measures :
  1. Effect of Oxygen and High Flow Rate on Exertional Dyspnea, as Measured by Borg Dyspnea Score at Isotime [ Time Frame: 3 days ]
    Borg dyspnea score at isotime used as outcome variable. Isotime defined as the time of the last set of measurements before completion of the baseline constant work rate test.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Diagnosis of cancer, with evidence of primary or secondary lung involvement.
  2. Average dyspnea Borg Scale >/= 4 of 10 with severe exertion over the past week
  3. Oxygen saturation >90% on ambient air at time of assessment
  4. Able to communicate in English or Spanish
  5. Karnofsky performance status >/=50%
  6. Age >/=18 years
  7. Seen at Supportive Care, cardiopulmonary center, thoracic radiation oncology or thoracic medical oncology.

Exclusion Criteria:

  1. Resting dyspnea modified Borg Scale >7 of 10 at enrollment.
  2. Severe obstructive lung disease (FEV1/FVC <70% post bronchodilator and forced expiratory volume in 1 second <30% predicted).
  3. Delirium (i.e., Memorial delirium rating scale >13).
  4. History of unstable angina or myocardial infarction in the last week.
  5. Acute pulmonary embolus or pulmonary infarction in the last week.
  6. Thrombosis of lower extremities in the last week.
  7. Acute myocarditis, pericarditis, or endocarditis in the last week.
  8. Symptomatic aortic stenosis or syncope in the last week.
  9. Suspected dissecting aneurysm.
  10. Severe untreated resting arterial hypertension (>200 mmHg systolic, >120 mmHg diastolic) at the time of enrollment.
  11. Uncontrolled arrhythmias causing symptoms or hemodynamic compromise in the last week.
  12. Uncontrolled heart failure in the last week.
  13. Pleural effusion requiring thoracentesis within 1 week of study enrollment or scheduled during the study period
  14. Airway obstruction requiring stenting within 1 week of study enrollment or scheduled during the study period
  15. 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
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
American Cancer Society, Inc.
Investigators
Principal Investigator: David Hui, MD 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
MRSG-14-148-01-CCE ( Other Grant/Funding Number: American Cancer Society )
NCI-2015-00418 ( Registry Identifier: NCI CTRP )
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

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

Keywords provided by M.D. Anderson Cancer Center:
Advanced cancers
Primary or secondary lung involvement
Dyspnea
Difficulty breathing
Stationary cycle test
Questionnaires
Surveys
High flow oxygen
High flow air
Low flow oxygen
Low flow air

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