Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-28 @ 5:41 AM
Study NCT ID:
NCT02357134
Status:
UNKNOWN
Last Update Posted:
2022-12-07
First Post:
2015-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D009369', 'term': 'Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dhui@mdanderson.org', 'phone': '(713) 792-6258', 'title': 'David Hui, MD/ Associate Professor, Palliative Care Medicine', 'organization': 'UT MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'before and after 3rd test during intervention phase, approximately up to 12 minutes', 'description': "In this protocol, the Adverse events were not measured as an absolute number. It was measured as a numeric rating score from 0 (not at all) to 10 (worst possible). So there are no Adverse events numbers in the Adverse Events section. As per the protocol, Adverse events were considered as a secondary outcome. Please see 'Adverse Events' under 'Outcome Measure.'", 'eventGroups': [{'id': 'EG000', 'title': 'High Flow Oxygen', 'description': 'High Flow Oxygen were delivered between 20 and 70 L/min', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Flow Air', 'description': 'High Flow Air were delivered between 20 and 70 L/min', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Low Flow Oxygen', 'description': 'Low Flow Oxygen were delivered at 2 L/min', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Low Flow Air', 'description': 'Low Flow Air were delivered at 2 L/min', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Modified Borg Scale Dyspnea Intensity at Isotime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Flow Oxygen', 'description': 'High Flow Oxygen were delivered between 20 and 70 L/min'}, {'id': 'OG001', 'title': 'High Flow Air', 'description': 'High Flow Air were delivered between 20 and 70 L/min'}, {'id': 'OG002', 'title': 'Low Flow Oxygen', 'description': 'Low Flow Oxygen were delivered at 2 L/min'}, {'id': 'OG003', 'title': 'Low Flow Air', 'description': 'Low Flow Air were delivered at 2 L/min'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-2.1', 'upperLimit': '-0.12'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.97', 'upperLimit': '0.6'}, {'value': '-1.8', 'groupId': 'OG002', 'lowerLimit': '-2.7', 'upperLimit': '-0.9'}, {'value': '-0.5', 'groupId': 'OG003', 'lowerLimit': '-1.3', 'upperLimit': '0.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of second exercise test and end of third exercise test, approximately up to 12 minutes', 'description': '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).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The data is provided for 44 participants who completed the study.'}, {'type': 'SECONDARY', 'title': 'Slope of Modified Borg Scale Dyspnea Unpleasantness Over Time During Constant Work Exercise Per Minute (Third Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Flow Oxygen', 'description': 'High Flow Oxygen were delivered between 20 and 70 L/min'}, {'id': 'OG001', 'title': 'High Flow Air', 'description': 'High Flow Air were delivered between 20 and 70 L/min'}, {'id': 'OG002', 'title': 'Low Flow Oxygen', 'description': 'Low Flow Oxygen were delivered at 2 L/min'}, {'id': 'OG003', 'title': 'Low Flow Air', 'description': 'Low Flow Air were delivered at 2 L/min'}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '0.62'}, {'value': '0.78', 'groupId': 'OG001', 'lowerLimit': '0.71', 'upperLimit': '0.87'}, {'value': '0.59', 'groupId': 'OG002', 'lowerLimit': '0.52', 'upperLimit': '0.67'}, {'value': '0.69', 'groupId': 'OG003', 'lowerLimit': '0.60', 'upperLimit': '0.79'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Third exercise test, approximately up to 12 minutes', 'description': '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.', 'unitOfMeasure': 'Units on a scale per minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The data is provided for 44 participants who completed the study.'}, {'type': 'SECONDARY', 'title': 'Modified Borg Scale Leg Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Flow Oxygen', 'description': 'High Flow Oxygen were delivered between 20 and 70 L/min'}, {'id': 'OG001', 'title': 'High Flow Air', 'description': 'High Flow Air were delivered between 20 and 70 L/min'}, {'id': 'OG002', 'title': 'Low Flow Oxygen', 'description': 'Low Flow Oxygen were delivered at 2 L/min'}, {'id': 'OG003', 'title': 'Low Flow Air', 'description': 'Low Flow Air were delivered at 2 L/min'}], 'classes': [{'categories': [{'measurements': [{'value': '0.59', 'groupId': 'OG000', 'lowerLimit': '0.53', 'upperLimit': '0.64'}, {'value': '0.91', 'groupId': 'OG001', 'lowerLimit': '0.82', 'upperLimit': '0.99'}, {'value': '0.65', 'groupId': 'OG002', 'lowerLimit': '0.58', 'upperLimit': '0.74'}, {'value': '0.81', 'groupId': 'OG003', 'lowerLimit': '0.71', 'upperLimit': '0.91'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Third exercise test, approximately up to 12 minutes', 'description': '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.', 'unitOfMeasure': 'Units on a scale per minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Exercise Endurance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Flow Oxygen', 'description': 'High Flow Oxygen were delivered between 20 and 70 L/min'}, {'id': 'OG001', 'title': 'High Flow Air', 'description': 'High Flow Air were delivered between 20 and 70 L/min'}, {'id': 'OG002', 'title': 'Low Flow Oxygen', 'description': 'Low Flow Oxygen were delivered at 2 L/min'}, {'id': 'OG003', 'title': 'Low Flow Air', 'description': 'Low Flow Air were delivered at 2 L/min'}], 'classes': [{'categories': [{'measurements': [{'value': '10.50', 'groupId': 'OG000', 'lowerLimit': '7.48', 'upperLimit': '13.52'}, {'value': '8.18', 'groupId': 'OG001', 'lowerLimit': '7.03', 'upperLimit': '9.34'}, {'value': '7.58', 'groupId': 'OG002', 'lowerLimit': '6.0', 'upperLimit': '9.17'}, {'value': '7.36', 'groupId': 'OG003', 'lowerLimit': '6.35', 'upperLimit': '8.37'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of third exercise test, approximately up to 12 minutes', 'description': "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", 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Flow Oxygen', 'description': 'High Flow Oxygen were delivered between 20 and 70 L/min'}, {'id': 'OG001', 'title': 'High Flow Air', 'description': 'High Flow Air were delivered between 20 and 70 L/min'}, {'id': 'OG002', 'title': 'Low Flow Oxygen', 'description': 'Low Flow Oxygen were delivered at 2 L/min'}, {'id': 'OG003', 'title': 'Low Flow Air', 'description': 'Low Flow Air were delivered at 2 L/min'}], 'classes': [{'title': 'Dry eyes', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '0.94', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}]}]}, {'title': 'Dry Nose', 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '-.033', 'spread': '0.89', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '0.67', 'groupId': 'OG003'}]}]}, {'title': 'Eye Irritation', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0.33', 'spread': '1.15', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}]}]}, {'title': 'Moisture in nose', 'categories': [{'measurements': [{'value': '1', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '1.56', 'groupId': 'OG001'}, {'value': '0', 'spread': '1.13', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '2.8', 'groupId': 'OG003'}]}]}, {'title': 'Nasal Prongs Uncomfortable', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.87', 'groupId': 'OG001'}, {'value': '-0.17', 'spread': '0.94', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '0.67', 'groupId': 'OG003'}]}]}, {'title': 'Suffocating', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '0.08', 'spread': '0.29', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'Anxious', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '1.58', 'groupId': 'OG003'}]}]}, {'title': 'Difficulty talking', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Before and after 3rd test during intervention phase, approximately up to 12 minutes', 'description': '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).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Flow Oxygen', 'description': 'High Flow Oxygen were delivered between 20 and 70 L/min.'}, {'id': 'FG001', 'title': 'High Flow Air', 'description': 'High Flow Air were delivered between 20 and 70 L/min.'}, {'id': 'FG002', 'title': 'Low Flow Oxygen', 'description': 'Low Flow Oxygen were delivered at 2 L/min.'}, {'id': 'FG003', 'title': 'Low Flow Air', 'description': 'Low Flow Air were delivered at 2 L/min'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited from the Supportive Care, Thoracic Radiation Oncology and Thoracic Medical Oncology clinics at MD Anderson Cancer Center, Houston, USA between 3/2015 and 4/2018 .', 'preAssignmentDetails': 'A total of 74 participants were enrolled but 45 patients were randomized for this study. 29 patients were not randomized for various reasons (became ineligible or too symptomatic to participate while waiting=14, scheduling conflict=9, exertional dyspnea too low=4, could not complete baseline test due to desaturation=1, hypertension during exercise=1)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'High Flow Oxygen', 'description': 'High Flow Oxygen were delivered between 20 and 70 L/min'}, {'id': 'BG001', 'title': 'High Flow Air', 'description': 'High Flow Air were delivered between 20 and 70 L/min'}, {'id': 'BG002', 'title': 'Low Flow Oxygen', 'description': 'Low Flow Oxygen were delivered at 2 L/min'}, {'id': 'BG003', 'title': 'Low Flow Air', 'description': 'Low Flow Air were delivered at 2 L/min'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '72'}, {'value': '67', 'groupId': 'BG001', 'lowerLimit': '55', 'upperLimit': '75'}, {'value': '63', 'groupId': 'BG002', 'lowerLimit': '51', 'upperLimit': '77'}, {'value': '62', 'groupId': 'BG003', 'lowerLimit': '47', 'upperLimit': '73'}, {'value': '63', 'groupId': 'BG004', 'lowerLimit': '47', 'upperLimit': '77'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '40', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', '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': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '38', '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': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cancer Type', 'classes': [{'title': 'Mesothelioma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}, {'title': 'Non Small Cell Lung Cancer', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}]}, {'title': 'Small Cell Lung Cancer', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer Stage', 'classes': [{'title': 'Localized', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Locally advanced', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}, {'title': 'Metastatic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbidities', 'classes': [{'title': 'COPD', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': 'Heart Failure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Asthma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The data is provided for 44 participants who completed the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-17', 'size': 426164, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-10T10:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-05', 'studyFirstSubmitDate': '2015-01-29', 'resultsFirstSubmitDate': '2021-02-18', 'studyFirstSubmitQcDate': '2015-02-05', 'lastUpdatePostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-27', 'studyFirstPostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Borg Scale Dyspnea Intensity at Isotime', 'timeFrame': 'End of second exercise test and end of third exercise test, approximately up to 12 minutes', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Slope of Modified Borg Scale Dyspnea Unpleasantness Over Time During Constant Work Exercise Per Minute (Third Test)', 'timeFrame': 'Third exercise test, approximately up to 12 minutes', 'description': '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.'}, {'measure': 'Modified Borg Scale Leg Discomfort', 'timeFrame': 'Third exercise test, approximately up to 12 minutes', 'description': '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.'}, {'measure': 'Exercise Endurance', 'timeFrame': 'End of third exercise test, approximately up to 12 minutes', 'description': "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"}, {'measure': 'Adverse Events', 'timeFrame': 'Before and after 3rd test during intervention phase, approximately up to 12 minutes', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyspnea', 'Malignant Neoplasm']}, 'referencesModule': {'references': [{'pmid': '33289280', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. 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).\n\nSECONDARY OBJECTIVES:\n\nI. Determine the completion rate of a randomized controlled trial of exertional dyspnea in cancer patients.\n\nII. 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).\n\nOUTLINE: 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.\n\nARM I: Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.\n\nARM II: Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session.\n\nARM III: Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.\n\nARM IV: Patients receive low-flow air via a nasal cannula during structured stationary bicycle exercise session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cancer, with evidence of primary or secondary lung involvement\n* Average dyspnea Borg Scale \\>= 4 of 10 with severe exertion over the past week\n* Oxygen saturation \\> 90% on ambient air at time of assessment\n* Able to communicate in English or Spanish\n* Karnofsky performance status \\>= 50%\n* Seen at Supportive Care, cardiopulmonary center, thoracic radiation oncology or thoracic medical oncology\n\nExclusion Criteria:\n\n* Resting dyspnea modified Borg Scale \\> 7 of 10 at enrollment\n* 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)\n* Delirium (i.e., Memorial Delirium Rating Scale \\> 13)\n* History of unstable angina or myocardial infarction in the last week\n* Acute pulmonary embolus or pulmonary infarction in the last week\n* Thrombosis of lower extremities in the last week\n* Acute myocarditis, pericarditis, or endocarditis in the last week\n* Symptomatic aortic stenosis or syncope in the last week\n* Suspected dissecting aneurysm\n* Severe untreated resting arterial hypertension (\\> 200 mmHg systolic, \\> 120 mmHg diastolic) at the time of enrollment\n* Uncontrolled arrhythmias causing symptoms or hemodynamic compromise in the last week\n* Uncontrolled heart failure in the last week\n* Pleural effusion requiring thoracentesis within 1 week of study enrollment or scheduled during the study period\n* Airway obstruction requiring stenting within 1 week of study enrollment or scheduled during the study period\n* Pneumonia requiring antibiotics at the time of study enrollment'}, 'identificationModule': {'nctId': 'NCT02357134', 'briefTitle': 'High-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'High-Flow Oxygen for Exertional Dyspnea in Cancer Patients', 'orgStudyIdInfo': {'id': '2014-0971'}, 'secondaryIdInfos': [{'id': 'NCI-2015-00418', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2014-0971', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (high-flow oxygen)', 'description': 'Patients receive high-flow oxygen via nasal prongs during a structured stationary bicycle exercise session.', 'interventionNames': ['Procedure: Oxygen Therapy', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (high-flow air)', 'description': 'Patients receive high-flow air via nasal prongs during a structured stationary bicycle exercise session', 'interventionNames': ['Procedure: Oxygen Therapy', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm III (low-flow oxygen)', 'description': 'Patients receive low-flow oxygen via a nasal cannula during a structured stationary bicycle exercise session.', 'interventionNames': ['Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Procedure: Respiratory Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm IV (low-flow air)', 'description': 'Patients receive low-flow air via a nasal cannula during a structured stationary bicycle exercise session.', 'interventionNames': ['Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration', 'Procedure: Respiratory Therapy']}], 'interventions': [{'name': 'Oxygen Therapy', 'type': 'PROCEDURE', 'otherNames': ['supplemental oxygen therapy'], 'description': 'Receive high-flow oxygen', 'armGroupLabels': ['Arm I (high-flow oxygen)']}, {'name': 'Oxygen Therapy', 'type': 'PROCEDURE', 'otherNames': ['supplemental oxygen therapy'], 'description': 'Receive high-flow air', 'armGroupLabels': ['Arm II (high-flow air)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (high-flow oxygen)', 'Arm II (high-flow air)', 'Arm III (low-flow oxygen)', 'Arm IV (low-flow air)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (high-flow oxygen)', 'Arm II (high-flow air)', 'Arm III (low-flow oxygen)', 'Arm IV (low-flow air)']}, {'name': 'Respiratory Therapy', 'type': 'PROCEDURE', 'description': 'Receive low-flow oxygen', 'armGroupLabels': ['Arm III (low-flow oxygen)']}, {'name': 'Respiratory Therapy', 'type': 'PROCEDURE', 'description': 'Receive low-flow air', 'armGroupLabels': ['Arm IV (low-flow air)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'David Hui', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}