Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-31 @ 9:33 AM
Study NCT ID:
NCT04620369
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2020-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rose Geranium in Sesame Oil Nasal Spray for the Improvement of Nasal Vestibulitis Symptoms in Cancer Patients Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
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Loprinzi', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 2 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A (Rose Geranium in Sesame Oil Nasal Spray)', 'description': 'Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 10, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm B (Isotonic Nasal Saline)', 'description': 'Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 9, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Arm A Crossover', 'description': 'Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Arm B Crossover', 'description': 'Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 4, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Blood and lymph sys disorders - Oth Spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Gen disord and admin site conds-Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Infections and infestations - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Superficial soft tissue fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Postnasal drip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Skin and subcut tissue disord - Oth spec', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE 5'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Rose Geranium in Sesame Oil Nasal Spray)', 'description': 'Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.\\>\\>\\> \\>\\>\\> Questionnaire Administration: Ancillary studies\\>\\>\\>\n\n\\>\\>\\> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally'}, {'id': 'OG001', 'title': 'Arm B (Isotonic Nasal Saline)', 'description': 'Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity.\\>\\>\\> \\>\\>\\> Placebo Administration: Instill isotonic nasal saline intranasally\\>\\>\\>\n\n\\>\\>\\> Questionnaire Administration: Ancillary studies'}], 'classes': [{'title': 'worsening of nasal symptoms', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'no change', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'some nasal symptom improvement', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 2 weeks after initiating the nasal spray', 'description': "Response is determined from a patient global impression of change scale and is defined as a patient reporting that the nasal symptom that was most prominent prior to starting the study has been moderately better or very much better 2 weeks after initiating the nasal spray. The number and percentage of patients experiencing a response 2 weeks after initiating\\>\\>\\> the nasal spray will be estimated within each randomized arm and the corresponding two-sided 95% exact (Clopper-Pearson) confidence interval provided. A between-arm comparison of the proportion of patients experiencing a response 2 weeks after initiating the nasal spray will be made using the Fisher's exact test.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Most Prominent Nasal Symptom Indicated at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Rose Geranium in Sesame Oil Nasal Spray)', 'description': 'Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.\n\n\\>\\>\\>\n\n\\>\\>\\> Questionnaire Administration: Ancillary studies\n\n\\>\\>\\>\n\n\\>\\>\\> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally'}, {'id': 'OG001', 'title': 'Arm B (Isotonic Nasal Saline)', 'description': 'Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity.\n\n\\>\\>\\>\n\n\\>\\>\\> Placebo Administration: Instill isotonic nasal saline intranasally\n\n\\>\\>\\>\n\n\\>\\>\\> Questionnaire Administration: Ancillary studies'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '100', 'spread': '0', 'groupId': 'OG000'}, {'value': '100', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '70.155', 'spread': '4.520', 'groupId': 'OG000'}, {'value': '91.458', 'spread': '5.598', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '65.0', 'spread': '5.154', 'groupId': 'OG000'}, {'value': '77.724', 'spread': '4.890', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 weeks after initiating the nasal spray', 'description': 'For the most prominent nasal symptom indicated at baseline, patients will record the severity on an ordinal scale of 1=mild, 2=moderate, 3=severe, and 4=very severe. Two weeks after initiating the nasal spray the patients will record the severity of the most prominent nasal symptom as 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. A shift table will be created to descriptively display the number of patients who record a 1, 2, 3, or 4 at baseline and the shift two-weeks after initiating the nasal spray. In addition, the within-patient change in severity of the most prominent nasal symptom will be calculated 2 weeks after initiating the nasal spray and summarized descriptively within each arm. The Wilcoxon rank-sum test will be performed, and the methods of Hodges and Lehmann will be applied to compute a point estimate and confidence interval for the difference in medians between the two arms.', 'unitOfMeasure': '"percentage of Week 0 score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Nasal Symptom Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Rose Geranium in Sesame Oil Nasal Spray)', 'description': 'Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.\n\n\\>\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies\n\n\\>\\>\n\n\\>\\> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally'}, {'id': 'OG001', 'title': 'Arm B (Isotonic Nasal Saline)', 'description': 'Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity.\n\n\\>\\>\n\n\\>\\> Placebo Administration: Instill isotonic nasal saline intranasally\n\n\\>\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies'}], 'classes': [{'title': 'Dryness Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.95', 'groupId': 'OG000', 'lowerLimit': '2.68', 'upperLimit': '3.23'}, {'value': '3.14', 'groupId': 'OG001', 'lowerLimit': '2.91', 'upperLimit': '3.39'}]}]}, {'title': 'Dryness Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.02', 'groupId': 'OG000', 'lowerLimit': '1.79', 'upperLimit': '2.26'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2.56', 'upperLimit': '3.04'}]}]}, {'title': 'Dryness Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1.72', 'upperLimit': '2.28'}, {'value': '2.46', 'groupId': 'OG001', 'lowerLimit': '2.15', 'upperLimit': '2.77'}]}]}, {'title': 'Tenderness/Discomfort Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.63', 'groupId': 'OG000', 'lowerLimit': '2.29', 'upperLimit': '2.96'}, {'value': '2.46', 'groupId': 'OG001', 'lowerLimit': '2.14', 'upperLimit': '2.79'}]}]}, {'title': 'Tenderness/Discomfort Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.65', 'groupId': 'OG000', 'lowerLimit': '1.40', 'upperLimit': '1.90'}, {'value': '2.25', 'groupId': 'OG001', 'lowerLimit': '1.91', 'upperLimit': '2.59'}]}]}, {'title': 'Tenderness/Discomfort Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.67', 'groupId': 'OG000', 'lowerLimit': '1.38', 'upperLimit': '1.96'}, {'value': '1.98', 'groupId': 'OG001', 'lowerLimit': '1.64', 'upperLimit': '2.31'}]}]}, {'title': 'Bleeding Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.56', 'groupId': 'OG000', 'lowerLimit': '2.24', 'upperLimit': '2.88'}, {'value': '2.68', 'groupId': 'OG001', 'lowerLimit': '2.36', 'upperLimit': '3.00'}]}]}, {'title': 'Bleeding Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '2.31'}, {'value': '2.48', 'groupId': 'OG001', 'lowerLimit': '2.18', 'upperLimit': '2.77'}]}]}, {'title': 'Bleeding Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.72', 'groupId': 'OG000', 'lowerLimit': '1.42', 'upperLimit': '2.02'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1.71', 'upperLimit': '2.29'}]}]}, {'title': 'Scabbing Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.72', 'groupId': 'OG000', 'lowerLimit': '2.40', 'upperLimit': '3.05'}, {'value': '2.49', 'groupId': 'OG001', 'lowerLimit': '2.13', 'upperLimit': '2.84'}]}]}, {'title': 'Scabbing Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.74', 'groupId': 'OG000', 'lowerLimit': '1.48', 'upperLimit': '2.00'}, {'value': '2.25', 'groupId': 'OG001', 'lowerLimit': '1.95', 'upperLimit': '2.55'}]}]}, {'title': 'Scabbing Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.63', 'groupId': 'OG000', 'lowerLimit': '1.36', 'upperLimit': '1.90'}, {'value': '2.17', 'groupId': 'OG001', 'lowerLimit': '1.83', 'upperLimit': '2.52'}]}]}, {'title': 'Sores Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.14', 'groupId': 'OG000', 'lowerLimit': '1.84', 'upperLimit': '2.44'}, {'value': '1.93', 'groupId': 'OG001', 'lowerLimit': '1.59', 'upperLimit': '2.27'}]}]}, {'title': 'Sores Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.58', 'groupId': 'OG000', 'lowerLimit': '1.32', 'upperLimit': '1.84'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.51', 'upperLimit': '2.09'}]}]}, {'title': 'Sores Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.47', 'groupId': 'OG000', 'lowerLimit': '1.21', 'upperLimit': '1.72'}, {'value': '1.78', 'groupId': 'OG001', 'lowerLimit': '1.48', 'upperLimit': '2.08'}]}]}, {'title': 'Most Prominent Symptom Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.09', 'groupId': 'OG000', 'lowerLimit': '2.82', 'upperLimit': '3.37'}, {'value': '3.17', 'groupId': 'OG001', 'lowerLimit': '2.92', 'upperLimit': '3.42'}]}]}, {'title': 'Most Prominent Symptom Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.09', 'groupId': 'OG000', 'lowerLimit': '1.79', 'upperLimit': '2.39'}, {'value': '2.73', 'groupId': 'OG001', 'lowerLimit': '2.46', 'upperLimit': '2.99'}]}]}, {'title': 'Most Prominent Symptom Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.93', 'groupId': 'OG000', 'lowerLimit': '1.63', 'upperLimit': '2.22'}, {'value': '2.39', 'groupId': 'OG001', 'lowerLimit': '2.09', 'upperLimit': '2.69'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 weeks after initiating the nasal spray', 'description': 'Each nasal symptom (dryness, pain, bleeding, and scabbing) will be descriptively summarized, tabulated, and plotted according to arm at baseline, and at 1 and 2 weeks post-baseline; additionally, will group patients according to baseline severity for each symptom and summarize changes over time and according to arm. Shift tables will also be generated to descriptively display the number of patients who record a 1, 2, 3, or 4 at baseline and the shift one- and two-weeks after initiating the nasal spray. The Nasal symptom scale is 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe with very severe being the worst outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients missed their post-baseline assessment'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Rose Geranium in Sesame Oil Nasal Spray)', 'description': 'Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.\n\n\\>\\>\n\n\\>\n\n\\>\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies\n\n\\>\\>\n\n\\>\n\n\\>\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally'}, {'id': 'OG001', 'title': 'Arm B (Isotonic Nasal Saline)', 'description': 'Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity.\n\n\\>\\>\n\n\\>\n\n\\>\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Placebo Administration: Instill isotonic nasal saline intranasally\n\n\\>\\>\n\n\\>\n\n\\>\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies'}], 'classes': [{'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 weeks after initiating the nasal spray', 'description': 'The constellation of AEs as scored using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 will be summarized within arms by reporting the number and percentage of patients. Specifically, to evaluate the AE profiles associated with each arm, the maximum grade for each type of AE will be recorded for each patient and frequency tables will be reviewed to determine overall patterns and compared between arms using Wilcoxon tests.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A (Rose Geranium in Sesame Oil Nasal Spray)', 'description': 'Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.\n\n\\>\\>\n\n\\>\n\n\\>\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies\n\n\\>\\>\n\n\\>\n\n\\>\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally'}, {'id': 'FG001', 'title': 'Arm B (Isotonic Nasal Saline)', 'description': 'Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity.\n\n\\>\\>\n\n\\>\n\n\\>\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Placebo Administration: Instill isotonic nasal saline intranasally\n\n\\>\\>\n\n\\>\n\n\\>\\>\n\n\\>\\>\n\n\\>\n\n\\>\\> Questionnaire Administration: Ancillary studies'}], 'periods': [{'title': 'Initial Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Crossover', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '2 patients on Arm A did crossover despite the protocol saying otherwise'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A (Rose Geranium in Sesame Oil Nasal Spray)', 'description': 'Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.\\> \\>\\>\\>\n\n\\>\n\n\\>\\>\\> Questionnaire Administration: Ancillary studies\\>\n\n\\>\\>\\>\n\n\\>\n\n\\>\\>\\> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally'}, {'id': 'BG001', 'title': 'Arm B (Isotonic Nasal Saline)', 'description': 'Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.\\> \\>\\>\\>\n\n\\>\n\n\\>\\>\\> Questionnaire Administration: Ancillary studies\\>\n\n\\>\\>\\>\n\n\\>\n\n\\>\\>\\> Rose Geranium in Sesame Oil Nasal Spray: Instill intranasally'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '59.3', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '59.3', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '83', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', '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': 'Prior treatments for nose symptoms', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': '3+', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior history of allergies or asthma', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Currently smoking', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Taking aspirin or blood thinners', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Most bothersome nasal symptom', 'classes': [{'title': 'Dryness', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Discomfort', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Bleeding', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Scabbing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Sores', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-19', 'size': 389728, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-25T15:35', 'hasProtocol': True}, {'date': '2022-10-05', 'size': 397993, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-07-25T15:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2020-10-27', 'resultsFirstSubmitDate': '2025-07-25', 'studyFirstSubmitQcDate': '2020-11-02', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-19', 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response', 'timeFrame': 'At 2 weeks after initiating the nasal spray', 'description': "Response is determined from a patient global impression of change scale and is defined as a patient reporting that the nasal symptom that was most prominent prior to starting the study has been moderately better or very much better 2 weeks after initiating the nasal spray. The number and percentage of patients experiencing a response 2 weeks after initiating\\>\\>\\> the nasal spray will be estimated within each randomized arm and the corresponding two-sided 95% exact (Clopper-Pearson) confidence interval provided. A between-arm comparison of the proportion of patients experiencing a response 2 weeks after initiating the nasal spray will be made using the Fisher's exact test."}], 'secondaryOutcomes': [{'measure': 'Severity of Most Prominent Nasal Symptom Indicated at Baseline', 'timeFrame': 'Up to 2 weeks after initiating the nasal spray', 'description': 'For the most prominent nasal symptom indicated at baseline, patients will record the severity on an ordinal scale of 1=mild, 2=moderate, 3=severe, and 4=very severe. Two weeks after initiating the nasal spray the patients will record the severity of the most prominent nasal symptom as 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe. A shift table will be created to descriptively display the number of patients who record a 1, 2, 3, or 4 at baseline and the shift two-weeks after initiating the nasal spray. In addition, the within-patient change in severity of the most prominent nasal symptom will be calculated 2 weeks after initiating the nasal spray and summarized descriptively within each arm. The Wilcoxon rank-sum test will be performed, and the methods of Hodges and Lehmann will be applied to compute a point estimate and confidence interval for the difference in medians between the two arms.'}, {'measure': 'Nasal Symptom Analysis', 'timeFrame': 'Up to 2 weeks after initiating the nasal spray', 'description': 'Each nasal symptom (dryness, pain, bleeding, and scabbing) will be descriptively summarized, tabulated, and plotted according to arm at baseline, and at 1 and 2 weeks post-baseline; additionally, will group patients according to baseline severity for each symptom and summarize changes over time and according to arm. Shift tables will also be generated to descriptively display the number of patients who record a 1, 2, 3, or 4 at baseline and the shift one- and two-weeks after initiating the nasal spray. The Nasal symptom scale is 0=none, 1=mild, 2=moderate, 3=severe, and 4=very severe with very severe being the worst outcome.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 2 weeks after initiating the nasal spray', 'description': 'The constellation of AEs as scored using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 will be summarized within arms by reporting the number and percentage of patients. Specifically, to evaluate the AE profiles associated with each arm, the maximum grade for each type of AE will be recorded for each patient and frequency tables will be reviewed to determine overall patterns and compared between arms using Wilcoxon tests.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic and Lymphoid Cell Neoplasm', 'Malignant Solid Neoplasm', 'Nasal Vestibulitis']}, 'referencesModule': {'references': [{'pmid': '38789656', 'type': 'DERIVED', 'citation': "Cathcart-Rake EJ, Steinert K, Smith D, Lewis-Peters S, Giridhar K, Novotny P, Dauer D, O'Connor A, Thome S, Erickson MK, Friday BB, Loprinzi CL. Rose geranium in sesame oil nasal spray to improve nasal vestibulitis symptoms: a randomized controlled trial. Support Care Cancer. 2024 May 24;32(6):379. doi: 10.1007/s00520-024-08580-6."}]}, 'descriptionModule': {'briefSummary': 'This phase III trial compares rose geranium in sesame oil nasal spray to isotonic nasal saline in improving symptoms of nasal vestibulitis in cancer patients receiving chemotherapy. Nasal (nose) symptoms (dryness, discomfort, bleeding, scabbing or sores) due to inflammation, termed nasal vestibulitis, is reported as a side effect of cancer-directed therapy. Rose geranium in sesame oil nasal spray may work better than isotonic nasal saline in improving symptoms of nasal vestibulitis.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine the ability of rose geranium in sesame oil nasal spray to alleviate nasal vestibulitis in patients undergoing systemic, antineoplastic therapy when compared with isotonic nasal saline.\n\nSECONDARY OBJECTIVE:\n\nI. To assess toxicities related to rose geranium in sesame oil nasal spray in this study situation.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM A: Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril twice daily (BID) on days 1-14 in the absence of unacceptable toxicity.\n\nARM B: Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* REGISTRATION-INCLUSION CRITERIA\n* Age \\>= 18 years and be diagnosed with cancer and receiving chemotherapy\n* Ability to provide informed consent\n* Willingness to complete questionnaires\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2\n* One or more of the following nasal symptoms for which the patient reports they would appreciate treatment. Symptoms must have started after the initiation of systemic, antineoplastic therapies, be attributed to the systemic, antineoplastic therapies, and symptoms must be reported as being moderate (corresponding to a score of 2) or worse on a scale from mild (1) to very severe (4) on at least one of the items below.\n\n * Dryness\n * Discomfort/pain\n * Bleeding\n * Scabbing\n * Sores\n\nExclusion Criteria:\n\n* REGISTRATION-EXCLUSION CRITERIA\n* Predisposition to epistaxis prior to the initiation of cancer-directed therapy (more than once a month over the previous year)\n* Planned initiation or continuation of any topical nasal treatment other than the studied nasal spray,(such as nasal steroids, Ayr nasal gel, Neosporin ointment or nasal administration of petroleum jelly). Taking Imitrex for migraines is acceptable\n* Previous exposure to rose geranium in sesame oil nasal spray\n* Concurrent upper respiratory tract infection\n* History of allergic or other adverse reactions to sesame oil or essential rose geranium oil\n* Any other reason that the study clinician or investigator feels precludes safe or appropriate inclusion in this study\n* Vulnerable populations: pregnant women, prisoners, mentally handicapped\n* RE-REGISTRATION\n* The patient will be un-blinded and determined to have been on the saline arm, when initially randomized'}, 'identificationModule': {'nctId': 'NCT04620369', 'briefTitle': 'Rose Geranium in Sesame Oil Nasal Spray for the Improvement of Nasal Vestibulitis Symptoms in Cancer Patients Receiving Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Rose Geranium in Sesame Oil Nasal Spray as an Agent to Improve Symptoms of Nasal Vestibulitis: A Phase III Double Blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MC19C1'}, 'secondaryIdInfos': [{'id': 'NCI-2020-08287', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A (rose geranium in sesame oil nasal spray)', 'description': 'Patients instill rose geranium in sesame oil nasal spray, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity.', 'interventionNames': ['Other: Questionnaire Administration', 'Drug: Rose Geranium in Sesame Oil Nasal Spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm B (isotonic nasal saline)', 'description': 'Patients instill isotonic nasal saline, 1 spray in each nostril BID on days 1-14 in the absence of unacceptable toxicity. After 2 weeks, patients may instill rose geranium in sesame oil nasal spray as in Arm A for an additional 2 weeks in the absence of unacceptable toxicity.', 'interventionNames': ['Drug: Placebo Administration', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Placebo Administration', 'type': 'DRUG', 'description': 'Instill isotonic nasal saline intranasally', 'armGroupLabels': ['Arm B (isotonic nasal saline)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm A (rose geranium in sesame oil nasal spray)', 'Arm B (isotonic nasal saline)']}, {'name': 'Rose Geranium in Sesame Oil Nasal Spray', 'type': 'DRUG', 'description': 'Instill intranasally', 'armGroupLabels': ['Arm A (rose geranium in sesame oil nasal spray)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56007', 'city': 'Albert Lea', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Health System in Albert Lea', 'geoPoint': {'lat': 43.64801, 'lon': -93.36827}}, {'zip': '56401', 'city': 'Brainerd', 'state': 'Minnesota', 'country': 'United States', 'facility': "Essentia Health Saint Joseph's Medical Center", 'geoPoint': {'lat': 46.35802, 'lon': -94.20083}}, {'zip': '56636', 'city': 'Deer River', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Essentia Health - Deer River Clinic', 'geoPoint': {'lat': 47.333, 'lon': -93.79272}}, {'zip': '56501', 'city': 'Detroit Lakes', 'state': 'Minnesota', 'country': 'United States', 'facility': "Essentia Health Saint Mary's - Detroit Lakes Clinic", 'geoPoint': {'lat': 46.81718, 'lon': -95.84533}}, {'zip': '55805', 'city': 'Duluth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Essentia Health Cancer Center', 'geoPoint': {'lat': 46.78327, 'lon': -92.10658}}, {'zip': '55731', 'city': 'Ely', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Essentia Health Ely Clinic', 'geoPoint': {'lat': 47.90324, 'lon': -91.86709}}, {'zip': '56542', 'city': 'Fosston', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Essentia Health - Fosston', 'geoPoint': {'lat': 47.57635, 'lon': -95.75141}}, {'zip': '55744', 'city': 'Grand Rapids', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Fairview Grand Itasca Clinic & Hospital', 'geoPoint': {'lat': 47.23717, 'lon': -93.53021}}, {'zip': '55746', 'city': 'Hibbing', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Essentia Health Hibbing Clinic', 'geoPoint': {'lat': 47.42715, 'lon': -92.93769}}, {'zip': '55746', 'city': 'Hibbing', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Fairview Range Medical Center', 'geoPoint': {'lat': 47.42715, 'lon': -92.93769}}, {'zip': '56649', 'city': 'International Falls', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Essentia Health - International Falls Clinic', 'geoPoint': {'lat': 48.60105, 'lon': -93.41098}}, {'zip': '56001', 'city': 'Mankato', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Health Systems-Mankato', 'geoPoint': {'lat': 44.15906, 'lon': -94.00915}}, {'zip': '55362', 'city': 'Monticello', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Monticello Cancer Center', 'geoPoint': {'lat': 45.30552, 'lon': -93.79414}}, {'zip': '56470', 'city': 'Park Rapids', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Essentia Health - Park Rapids', 'geoPoint': {'lat': 46.92218, 'lon': -95.05863}}, {'zip': '55371', 'city': 'Princeton', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Fairview Northland Medical Center', 'geoPoint': {'lat': 45.56997, 'lon': -93.58163}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '55072', 'city': 'Sandstone', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Essentia Health Sandstone', 'geoPoint': {'lat': 46.13106, 'lon': -92.86742}}, {'zip': '56701', 'city': 'Thief River Falls', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Sanford Thief River Falls Medical Center', 'geoPoint': {'lat': 48.11914, 'lon': -96.18115}}, {'zip': '55792', 'city': 'Virginia', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Essentia Health Virginia Clinic', 'geoPoint': {'lat': 47.52326, 'lon': -92.53657}}, {'zip': '56187', 'city': 'Worthington', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Sanford Cancer Center Worthington', 'geoPoint': {'lat': 43.61996, 'lon': -95.5964}}], 'overallOfficials': [{'name': 'Charles L Loprinzi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}