Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT01832402
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2013-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, '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': 'Baseline, up to 2 hours in one single visit', 'description': 'Each adverse effect was measured using an 11-point numeric rating scale (0=none, 10=worst) before drug administration and immediately after the 2nd 6 minute walk test (approximately 30 minutes later) and immediately again after the 3rd 6 minute walk test (again measured approximately 30 minutes later).', 'eventGroups': [{'id': 'EG000', 'title': 'Interventional (Fentanyl Pectin Nasal Spray) Second Walk Test', 'description': 'Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control (Placebo), Second Walk Test', 'description': 'Received similar number of Placebo Spray 20 minutes before 2nd 6 minute walk tests.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Interventional (Fentanyl Pectin Nasal Spray),Third Walk Test', 'description': 'Received Fentanyl Pectin Nasal Spray 20 minutes before 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Control (Placebo), Third Walk Test', 'description': 'Received similar Placebo Spray 20 minutes before 3rd 6 minute walk tests.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Stuffy Nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nose Dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dyspnea Numeric Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group (Fentanyl Pectin Nasal Spray)', 'description': 'Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd and 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.'}, {'id': 'OG001', 'title': 'Controlled Group (Placebo)', 'description': 'Received similar number of Placebo Spray 20 minutes before 2nd and 3rd 6 minute walk tests.'}], 'classes': [{'title': 'Mean difference between 1st and 2nd walk tests', 'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '-0.6'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-3.3', 'upperLimit': '-0.1'}]}]}, {'title': 'Mean difference between 1st and 3rd walk tests', 'categories': [{'measurements': [{'value': '-2.3', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '-0.7'}, {'value': '-2.5', 'groupId': 'OG001', 'lowerLimit': '-4.2', 'upperLimit': '-0.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1.5 to 2 hours on a Single visit', 'description': 'Our primary outcome was dyspnea intensity "now" using a dyspnea numeric rating scale that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference of dyspnea numeric rating scale between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests. 6 minute walk tests were carried out following guidelines from the American Thoracic Society.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dyspnea Borg Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group (Fentanyl Pectin Nasal Spray)', 'description': 'Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd and 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.'}, {'id': 'OG001', 'title': 'Controlled Group (Placebo)', 'description': 'Received similar number of Placebo Spray 20 minutes before 2nd and 3rd 6 minute walk tests.'}], 'classes': [{'title': 'Mean difference between 1st and 2nd walk tests', 'categories': [{'measurements': [{'value': '-1.8', 'groupId': 'OG000', 'lowerLimit': '-3.1', 'upperLimit': '-0.4'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-3.3', 'upperLimit': '-0.1'}]}]}, {'title': 'Mean difference between 1st and 3rd walk tests', 'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '0'}, {'value': '-2.4', 'groupId': 'OG001', 'lowerLimit': '-4.2', 'upperLimit': '-0.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1.5 to 2 hours on a Single visit', 'description': 'Assessed dyspnea using the modified Dyspnea Borg Scale that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference of modified Dyspnea Borg scale between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Walk Distance at 6 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Group (Fentanyl Pectin Nasal Spray)', 'description': 'Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd and 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.'}, {'id': 'OG001', 'title': 'Control Group (Placebo)', 'description': 'Received similar number of Placebo Spray 20 minutes before 2nd and 3rd 6 minute walk tests.'}], 'classes': [{'title': 'Mean difference between 1st and 2nd walk tests', 'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '46.2'}, {'value': '16.3', 'groupId': 'OG001', 'lowerLimit': '-8.6', 'upperLimit': '41.3'}]}]}, {'title': 'Mean difference between 1st and 3rd walk tests', 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '48.2'}, {'value': '14.6', 'groupId': 'OG001', 'lowerLimit': '-11.0', 'upperLimit': '40.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1.5 to 2 hours on a Single visit', 'description': 'Compared the mean difference of distance between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests.', 'unitOfMeasure': 'meters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group (Fentanyl Pectin Nasal Spray)', 'description': 'Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd and 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.'}, {'id': 'FG001', 'title': 'Controlled Group (Placebo)', 'description': 'Received similar number of Placebo Spray 20 minutes before 2nd and 3rd 6 minute walk tests.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Received Allocated Medication', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Completed Study With Correct Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Completed Study With Incorrect Dose', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Declining Performance status', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Adult participants (age\\>18) with an active diagnosis of cancer were recruited between 6/2013 and 3/2015 from the Supportive Care Center outpatient clinic of MD Anderson Cancer Center who satisfied the inclusion and exclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group (Fentanyl Pectin Nasal Spray)', 'description': 'Received Fentanyl Pectin Nasal Spray 20 minutes before 2nd and 3rd 6 minute walk tests, dose equivalent to 15-25% of total daily opioid dose each time.'}, {'id': 'BG001', 'title': 'Controlled Group (Placebo)', 'description': 'Received similar number of Placebo Spray 20 minutes before 2nd and 3rd 6 minute walk tests.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'groupId': 'BG000', 'lowerLimit': '44.7', 'upperLimit': '58.3'}, {'value': '53.3', 'groupId': 'BG001', 'lowerLimit': '45.0', 'upperLimit': '61.6'}, {'value': '52.4', 'groupId': 'BG002', 'lowerLimit': '47.5', 'upperLimit': '57.4'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education', 'classes': [{'title': 'High School or less', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'College', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Advanced Degree', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer Type', 'classes': [{'title': 'GastroIntestinal Cancer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Breast Cancer', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Lung Cancer', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Genitourinary Cancer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Gynecologic Cancer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Hematologic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Others', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cancer Stage', 'classes': [{'title': 'Metastatic Stage', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Localized/Locally advanced', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbidity', 'classes': [{'title': 'Asthma', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'COPD', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Heart Failure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intention to treat analysis participants data'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-11-05', 'size': 549734, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-31T11:24', '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': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-06', 'studyFirstSubmitDate': '2013-04-10', 'resultsFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2013-04-11', 'lastUpdatePostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-18', 'studyFirstPostDateStruct': {'date': '2013-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dyspnea Numeric Rating Scale', 'timeFrame': '1.5 to 2 hours on a Single visit', 'description': 'Our primary outcome was dyspnea intensity "now" using a dyspnea numeric rating scale that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference of dyspnea numeric rating scale between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests. 6 minute walk tests were carried out following guidelines from the American Thoracic Society.'}], 'secondaryOutcomes': [{'measure': 'Dyspnea Borg Scale', 'timeFrame': '1.5 to 2 hours on a Single visit', 'description': 'Assessed dyspnea using the modified Dyspnea Borg Scale that ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"). Measured the mean difference of modified Dyspnea Borg scale between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests.'}, {'measure': 'Walk Distance at 6 Minutes', 'timeFrame': '1.5 to 2 hours on a Single visit', 'description': 'Compared the mean difference of distance between the first and second 6 Minute Walk Tests and between the first and third 6 Minute Walk Tests.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Cancers', 'Exercise-Induced Breakthrough Dyspnea', 'Shortness of breath', 'Fentanyl pectin nasal spray', 'Placebo nasal spray', 'Walk test', 'Questionnaires', 'Surveys', 'Mental ability tests'], 'conditions': ['Advanced Cancers']}, 'referencesModule': {'references': [{'pmid': '27401508', 'type': 'DERIVED', 'citation': 'Hui D, Kilgore K, Park M, Williams J, Liu D, Bruera E. Impact of Prophylactic Fentanyl Pectin Nasal Spray on Exercise-Induced Episodic Dyspnea in Cancer Patients: A Double-Blind, Randomized Controlled Trial. J Pain Symptom Manage. 2016 Oct;52(4):459-468.e1. doi: 10.1016/j.jpainsymman.2016.05.013. Epub 2016 Jul 9.'}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical research study is to learn if fentanyl nasal spray can help to control shortness of breath in patients who have been treated or are being treated for cancer.\n\nFentanyl is commonly used for treatment of cancer pain. It may help patients with their shortness of breath as well.\n\nIn this study, fentanyl will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.', 'detailedDescription': 'Study Groups:\n\nIf you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to receive either fentanyl or placebo. You will have an equal chance of being assigned to either group. Neither you nor the study staff will know to which group you have been assigned. However, if needed for your safety, the study staff will be able to find out what you are receiving.\n\nStudy Drug/Placebo Administration:\n\nBefore you receive the study drug/placebo, you will walk back and forth in an indoor hallway for up to 6 minutes. You may feel out of breath or become exhausted. You may slow down, stop, and rest at any time you need to.\n\nAfter that, you will sit down and rest (for about 30 minutes).\n\nYou will then be given the study drug/placebo by a nasal spray. You will then wait for another 20 minutes and repeat the walking test.\n\nAfter that, you will sit down and rest (for about 30 minutes).\n\nYou will then be given the study drug/placebo again by a nasal spray. You will then wait for another 20 minutes and repeat the walking test for a third time.\n\nStudy Visit:\n\nDuring your study visit, the study staff will collect information from your medical record about your age, sex, race, disease type, your performance status, any drugs you are taking, and possible causes of shortness of breath.\n\nBefore each walk test, you will complete the questionnaires about your symptoms.\n\nBefore and after each walk test, the study staff will record your heart rate, breathing rate, and the level of oxygen in your blood using a measuring device that will be clipped onto your finger. The study staff will also ask you 3 questions about how hard it is to catch your breath and your level of tiredness.\n\nDuring each walk test, you will be asked 6 times how hard it is to catch your breath. The distance you walked and how often and for how long you stopped will be recorded.\n\nBefore and after the second and third walk tests, the study staff will ask you about any side effects from the study drug/placebo that you may be having.\n\nDuring the rest period between the walk tests, you may be asked several times how hard it is to catch your breath.\n\nAfter each walk test, you will also be asked to complete 4 tests of your mental abilities, including finger tapping, simple mathematics questions (addition, subtraction, multiplication, division), recall of numbers, and recall of objects. It should take 15 minutes to complete these tests.\n\nAt the end of the study visit, you will complete 1 questionnaire that asks if you think the study drug/placebo is helping you, and how satisfied you are with the study. It should take about 5 minutes to complete the questionnaire.\n\nLength of Study:\n\nYou will be on this study for up to 3 hours. You will be taken off study if intolerable side effects occur during the study.\n\nThis is an investigational study. Fentanyl is FDA approved and commercially available for the treatment of pain. Its use to help with shortness of breath is investigational.\n\nUp to 25 patients will be enrolled in this study. All will be enrolled at MD Anderson.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of cancer\n2. Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average intensity level \\>=3/10 on the numeric rating scale\n3. Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service or Thoracic Medical Oncology\n4. Ambulatory and able to walk with or without walking aid\n5. On strong opioids with morphine equivalent daily dose of 80-500 mg, with stable (i.e. +/- 30%) regular dose over the last 24 hours\n6. Karnofsky performance status \\>=50%\n7. Age 18 or older\n8. Able to complete study assessments\n\nExclusion Criteria:\n\n1. Dyspnea at rest \\>=7/10 at the time of enrollment\n2. Supplemental oxygen requirement \\>6 L per minute\n3. Delirium (i.e. Memorial delirium rating scale \\>13)\n4. History of unstable angina or myocardial infarction 1 month prior to study enrollment\n5. Resting heart rate \\>120 at the time of study enrollment\n6. Systolic pressure \\>180 mmHg or diastolic pressure \\>100 mmHg at the time of study enrollment\n7. History of active opioid abuse within the past 12 months\n8. History of allergy to fentanyl\n9. Unwilling to provide informed consent\n10. Patients who currently have no evidence of disease'}, 'identificationModule': {'nctId': 'NCT01832402', 'briefTitle': 'Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Preliminary Study of Prophylactic Fentanyl Pectin Nasal Spray (FPNS) for Exercise-Induced Breakthrough Dyspnea', 'orgStudyIdInfo': {'id': '2012-1169'}, 'secondaryIdInfos': [{'id': 'NCI-2013-00961', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fentanyl Pectin Nasal Spray', 'description': 'Fentanyl pectin nasal (FPNS) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD). FPNS administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test. Walk test administered before first dose of FPNS. Participant will rest for 30 minutes after walk test. FPNS administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. FPNS administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes. Questionnaires completed at baseline, before each walk test, and at end of final walk test. Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.', 'interventionNames': ['Drug: Fentanyl Pectin Nasal Spray', 'Other: Walk Test', 'Behavioral: Questionnaires', 'Behavioral: Mental Ability Tests']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Nasal Spray', 'description': 'Placebo nasal spray administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test. Walk test administered before first dose of placebo nasal spray. Participant will rest for 30 minutes after walk test. Placebo nasal spray administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. Placebo nasal spray administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes. Questionnaires completed at baseline, before each walk test, and at end of final walk test. Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.', 'interventionNames': ['Drug: Placebo Nasal Spray', 'Other: Walk Test', 'Behavioral: Questionnaires', 'Behavioral: Mental Ability Tests']}], 'interventions': [{'name': 'Fentanyl Pectin Nasal Spray', 'type': 'DRUG', 'description': 'Fentanyl pectin nasal (FPNS) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test.', 'armGroupLabels': ['Fentanyl Pectin Nasal Spray']}, {'name': 'Placebo Nasal Spray', 'type': 'DRUG', 'description': 'Placebo nasal spray administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test.', 'armGroupLabels': ['Placebo Nasal Spray']}, {'name': 'Walk Test', 'type': 'OTHER', 'description': 'Walk test administered before first dose of drug/placebo nasal spray. Participant will rest for 30 minutes after walk test. Drug/placebo nasal spray administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. Drug/placebo nasal spray administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes.', 'armGroupLabels': ['Fentanyl Pectin Nasal Spray', 'Placebo Nasal Spray']}, {'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'otherNames': ['Surveys'], 'description': 'Questionnaires completed at baseline, before each walk test, and at end of final walk test.', 'armGroupLabels': ['Fentanyl Pectin Nasal Spray', 'Placebo Nasal Spray']}, {'name': 'Mental Ability Tests', 'type': 'BEHAVIORAL', 'description': 'Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.', 'armGroupLabels': ['Fentanyl Pectin Nasal Spray', 'Placebo Nasal Spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'David Hui, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Depomed', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}