Houston, Texas 77030


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT02357134


Primary Contact:

Principal Investigator
David Hui, MD
M.D. Anderson Cancer Center

David Hui, MD
Phone: 713-792-6085


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

MD Anderson Health Information Specialist
Phone: 877-632-6789

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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