Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-02-21 @ 10:09 AM
Study NCT ID:
NCT02932332
Status:
COMPLETED
Last Update Posted:
2023-04-21
First Post:
2016-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dhui@mdanderson.org', 'phone': '713-792-6258', 'title': 'David Hui, MD, Associate Professor/Palliative Care Med', 'organization': 'UT MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'baseline and 10 minutes of each intervention.', '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.", 'eventGroups': [{'id': 'EG000', 'title': 'High Flow Air', 'description': 'High Flow Air was delivered between 20 and 60 L/min.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Flow Oxygen', 'description': 'High Flow Oxygen was delivered between 20 and 60 L/min.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 6, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Low Flow Air', 'description': 'Low Flow Air was delivered at 2L/min.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 4, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Low Flow Oxygen', 'description': 'Low Flow Oxygen was delivered at 2L/min.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 7, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry Nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Moisture in nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal prong uncomfortable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling of suffocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trouble talking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Dyspnea Numeric Score Between 0 and 10 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx)', '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.'}, {'id': 'OG001', 'title': 'Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir)', '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.'}, {'id': 'OG002', 'title': 'Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx)', '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.'}, {'id': 'OG003', 'title': 'Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir)', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '-0.5'}, {'value': '-1.8', 'groupId': 'OG001', 'lowerLimit': '-2.8', 'upperLimit': '-0.7'}, {'value': '-0.6', 'groupId': 'OG002', 'lowerLimit': '-1.3', 'upperLimit': '0.2'}, {'value': '-0.5', 'groupId': 'OG003', 'lowerLimit': '-1.0', 'upperLimit': '0.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (baseline) minutes and at 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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the first intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Modified Borg Scale Intensity Between 0 and 10 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx)', '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.'}, {'id': 'OG001', 'title': 'Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir)', '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.'}, {'id': 'OG002', 'title': 'Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx)', '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.'}, {'id': 'OG003', 'title': 'Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir)', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '0.2'}, {'value': '-1.8', 'groupId': 'OG001', 'lowerLimit': '-2.8', 'upperLimit': '-0.7'}, {'value': '-0.1', 'groupId': 'OG002', 'lowerLimit': '-0.4', 'upperLimit': '0.2'}, {'value': '-0.5', 'groupId': 'OG003', 'lowerLimit': '-1.2', 'upperLimit': '0.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (baseline) minutes and at 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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the first intervention'}, {'type': 'SECONDARY', 'title': 'Change in Modified Borg Scale Unpleasantness Between 0 and 10 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx)', '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.'}, {'id': 'OG001', 'title': 'Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir)', '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.'}, {'id': 'OG002', 'title': 'Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx)', '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.'}, {'id': 'OG003', 'title': 'Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir)', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '0.5'}, {'value': '-1.8', 'groupId': 'OG001', 'lowerLimit': '-3.3', 'upperLimit': '-0.4'}, {'value': '-0.6', 'groupId': 'OG002', 'lowerLimit': '-1.5', 'upperLimit': '0.2'}, {'value': '-0.7', 'groupId': 'OG003', 'lowerLimit': '-1.6', 'upperLimit': '0.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (baseline) minutes and at 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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the first intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx)', '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'}, {'id': 'FG001', 'title': 'Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir)', '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'}, {'id': 'FG002', 'title': 'Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx)', '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'}, {'id': 'FG003', 'title': 'Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir)', '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'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Intervention 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Intervention 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Intervention 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Intervention 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Chest pain', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Not Dyspneic cough', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': '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)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 High Flow Air (HFAir-LFAir-HFOx-LFOx)', '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'}, {'id': 'BG001', 'title': 'Group 2 High Flow Oxygen (HFOx-HFAir-LFOx-LFAir)', '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'}, {'id': 'BG002', 'title': 'Group 3 Low Flow Air (LFAir-LFOx-HFAir-HFOx)', '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'}, {'id': 'BG003', 'title': 'Group 4 Low Flow Oxygen (LFOx-HFOx-LFAir-HFAir)', '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'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '35', 'upperLimit': '68'}, {'value': '48', 'groupId': 'BG001', 'lowerLimit': '29', 'upperLimit': '62'}, {'value': '50', 'groupId': 'BG002', 'lowerLimit': '36', 'upperLimit': '59'}, {'value': '51', 'groupId': 'BG003', 'lowerLimit': '34', 'upperLimit': '70'}, {'value': '51', 'groupId': 'BG004', 'lowerLimit': '29', 'upperLimit': '70'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cancer Stage', 'classes': [{'title': 'II', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'III', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'IV', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Cancer is typically labeled in stages from I to IV, with IV being the most serious.', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer Type', 'classes': [{'title': 'Breast', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Gastrointestinal', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Genitourinary', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Gynecological', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Hematologic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Thoracic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Dyspnea for reason of admission', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Supplement Oxygen', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'It included all randomized participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-26', 'size': 369539, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-07T12:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-20', 'studyFirstSubmitDate': '2016-10-12', 'resultsFirstSubmitDate': '2021-07-20', 'studyFirstSubmitQcDate': '2016-10-12', 'lastUpdatePostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-24', 'studyFirstPostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Dyspnea Numeric Score Between 0 and 10 Minutes', 'timeFrame': '0 (baseline) minutes and at 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."}], 'secondaryOutcomes': [{'measure': 'Change in Modified Borg Scale Intensity Between 0 and 10 Minutes', 'timeFrame': '0 (baseline) minutes and at 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."}, {'measure': 'Change in Modified Borg Scale Unpleasantness Between 0 and 10 Minutes', 'timeFrame': '0 (baseline) minutes and at 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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['shortness of breath', 'oxygen', 'breathing therapies'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '33289276', 'type': 'DERIVED', 'citation': 'Hui D, Hernandez F, Urbauer D, Thomas S, Lu Z, Elsayem A, Bruera E. High-Flow Oxygen and High-Flow Air for Dyspnea in Hospitalized Patients with Cancer: A Pilot Crossover Randomized Clinical Trial. Oncologist. 2021 May;26(5):e883-e892. doi: 10.1002/onco.13622. Epub 2020 Dec 15.'}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Study Groups and Procedures:\n\nIf you agree to take part in this study, you will receive 4 different breathing therapies:\n\n* High-flow oxygen\n* Low-flow oxygen\n* High-flow air and\n* Low-flow air\n\nThe 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.\n\nAll 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.\n\nAt 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.\n\nAfter 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.\n\nLength of Study:\n\nYou 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.\n\nThis 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.\n\nUp to 36 participants will be enrolled in this study. All will take part at MD Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of cancer\n2. Patients seen by palliative care, thoracic oncology, pulmonary medicine, or emergency care at MD Anderson Cancer Center\n3. Dyspnea Numeric Rating Scale at rest \\>/=3 of 10 (average over last 24 hour)\n4. Non-hypoxemic (i.e. oxygen saturation \\>90% on ambient air)\n5. Able to communicate in English or Spanish\n6. Age \\>/= 18 years\n7. Able to tolerate high-flow oxygen/air\n\nExclusion Criteria:\n\n1. Memorial Delirium Rating Scale \\>13\n2. Hemodynamic instability\n3. Respiratory failure requiring mechanical ventilation or non-invasive ventilation\n4. Frequent use of rescue opioids \\>8x/day or rescue bronchodilators \\>8x/day over last 24 hours\n5. Currently requiring high flow oxygen for oxygenation'}, 'identificationModule': {'nctId': 'NCT02932332', 'briefTitle': 'High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients', 'orgStudyIdInfo': {'id': '2016-0282'}, 'secondaryIdInfos': [{'id': 'NCI-2017-00186', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High-flow oxygen: Initial Therapy', 'description': '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.', 'interventionNames': ['Other: High-flow Oxygen', 'Other: Low-flow Oxygen', 'Other: High-flow Air', 'Other: Low-flow Air']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low-flow oxygen: Initial Therapy', 'description': '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.', 'interventionNames': ['Other: High-flow Oxygen', 'Other: Low-flow Oxygen', 'Other: High-flow Air', 'Other: Low-flow Air']}, {'type': 'SHAM_COMPARATOR', 'label': 'High-flow air: Initial Therapy', 'description': '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.', 'interventionNames': ['Other: High-flow Oxygen', 'Other: Low-flow Oxygen', 'Other: High-flow Air', 'Other: Low-flow Air']}, {'type': 'SHAM_COMPARATOR', 'label': 'Low-flow air: Initial Therapy', 'description': '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.', 'interventionNames': ['Other: High-flow Oxygen', 'Other: Low-flow Oxygen', 'Other: High-flow Air', 'Other: Low-flow Air']}], 'interventions': [{'name': 'High-flow Oxygen', 'type': 'OTHER', 'otherNames': ['HFOx'], 'description': '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%.', 'armGroupLabels': ['High-flow air: Initial Therapy', 'High-flow oxygen: Initial Therapy', 'Low-flow air: Initial Therapy', 'Low-flow oxygen: Initial Therapy']}, {'name': 'Low-flow Oxygen', 'type': 'OTHER', 'otherNames': ['LFOx'], 'description': '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.', 'armGroupLabels': ['High-flow air: Initial Therapy', 'High-flow oxygen: Initial Therapy', 'Low-flow air: Initial Therapy', 'Low-flow oxygen: Initial Therapy']}, {'name': 'High-flow Air', 'type': 'OTHER', 'otherNames': ['HFAir'], 'description': '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.', 'armGroupLabels': ['High-flow air: Initial Therapy', 'High-flow oxygen: Initial Therapy', 'Low-flow air: Initial Therapy', 'Low-flow oxygen: Initial Therapy']}, {'name': 'Low-flow Air', 'type': 'OTHER', 'otherNames': ['LFAir'], 'description': '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.', 'armGroupLabels': ['High-flow air: Initial Therapy', 'High-flow oxygen: Initial Therapy', 'Low-flow air: Initial Therapy', 'Low-flow oxygen: Initial Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'David Hui, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The University of Texas MD Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}