Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT00591305
Status:
TERMINATED
Last Update Posted:
2017-05-18
First Post:
2007-12-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
New Therapy of Laryngeal Papilloma In Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010212', 'term': 'Papilloma'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C016392', 'term': "3,3'-diindolylmethane"}, {'id': 'D054025', 'term': 'Lasers, Dye'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zwang@bu.edu', 'phone': '617-414-1590', 'title': 'Zhi Wang, MD', 'organization': 'Boston Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'There was only one participant due to difficulty in recruitment which resulted in early termination of the trial.'}}, 'adverseEventsModule': {'timeFrame': '3 months after surgery', 'eventGroups': [{'id': 'EG000', 'title': 'PDL+DIM Pill', 'description': 'once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PDL+Placebo Pill', 'description': 'once-time PDL treatment by PDL on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'laser+dietary DIM'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'laser only without DIM'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Recurrence of pailloma at 5 months', 'description': 'vocal lesion size and area after 5 month with surgery visible lesion found in \\>50% of the treated tissue area, after surgery', 'unitOfMeasure': 'case', 'reportingStatus': 'POSTED', 'populationDescription': 'participants received at least one of two interventions'}, {'type': 'SECONDARY', 'title': 'Estradiol Level in Blood Pre Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'laser+diatary DIM'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'laser only without DIM'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before treatment at baseline', 'description': 'determine side-effect by comparing Estradiol level in blood before and after treatment', 'unitOfMeasure': 'pg/ml', 'reportingStatus': 'POSTED', 'populationDescription': 'failure for any meaningful analysis as only 1 participant in this study'}, {'type': 'SECONDARY', 'title': 'Estradiol Level in Blood Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'laser+diatary DIM'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'laser only without DIM'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 month', 'description': 'determine side-effect by comparing Estradiol level in blood before and after treatment', 'unitOfMeasure': 'pg/ml', 'reportingStatus': 'POSTED', 'populationDescription': 'failure for any meaningful analysis as only 1 participant in this study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PDL+DIM Pill', 'description': 'once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects\n\ndiindolylmethane (DIM): 3-month DIM\n\n585 nm pulsed dye laser: once-time PDL'}, {'id': 'FG001', 'title': 'PDL+Placebo Pill', 'description': 'once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects\n\n585 nm pulsed dye laser: once-time PDL'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': '1st Follow-up in 2 Wks After Surgery', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '5 month follow up study', 'preAssignmentDetails': 'There was only one participant due to difficulty in recruitment which resulted in early termination of the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PDL+DIM Pill', 'description': 'once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects\n\ndiindolylmethane (DIM): 3-month DIM\n\n585 nm pulsed dye laser: once-time PDL'}, {'id': 'BG001', 'title': 'PDL+Placebo Pill', 'description': 'once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects\n\n585 nm pulsed dye laser: once-time PDL'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'There was only one participant due to difficulty in recruitment which resulted in early termination of the trial.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'treatment to be selected based on a randomized number table, blinded to participants'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'laser only vs laser+ a dietary agent (DIM)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'insufficient resource for recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2007-12-31', 'resultsFirstSubmitDate': '2017-02-24', 'studyFirstSubmitQcDate': '2008-01-10', 'lastUpdatePostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-16', 'studyFirstPostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Cases With Recurrence of Laryngeal Papilloma in 5 Months', 'timeFrame': 'Recurrence of pailloma at 5 months', 'description': 'vocal lesion size and area after 5 month with surgery visible lesion found in \\>50% of the treated tissue area, after surgery'}], 'secondaryOutcomes': [{'measure': 'Estradiol Level in Blood Pre Treatment', 'timeFrame': 'Before treatment at baseline', 'description': 'determine side-effect by comparing Estradiol level in blood before and after treatment'}, {'measure': 'Estradiol Level in Blood Post Treatment', 'timeFrame': '5 month', 'description': 'determine side-effect by comparing Estradiol level in blood before and after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['papilloma', 'PDL', 'diindolylmethane', 'recurrence'], 'conditions': ['Papilloma']}, 'descriptionModule': {'briefSummary': 'This study will determine efficacy of a new and combined treatment of laryngeal recurrent respiratory papillomatosis (RRP), by using a 585 nm pulsed dye laser (PDL) and a dietary supplement, diindolylmethane (DIM). We will compare this new treatment with PDL-only, in a total of 30 children (15 of each treatment), to determine whether this combined treatment would be effective and safe in preventing the RRP recurrence. This is the first study to combine PDL technique with DIM, to develop a new, voice-preserving and long-term effective method of managing laryngeal RRP in children.', 'detailedDescription': 'Previous studies have demonstrated that PDL can be used to remove lesions on the vocal cords and elsewhere in the throat causing less damage to surface tissues than other commonly used lasers. In our proposed clinical study, we seek to compare treatment efficacy for RRP by combining PDL with DIM, versus PDL-only treatment, in a total of 30 children with laryngeal papilloma. We will determine whether this combined treatment would be effective and safe in preventing or delaying the RRP recurrence while preserving voice quality. 30 children will be divided randomly into two treatment groups, 15 in each. The experimental group will receive one-time PDL treatment, followed by 3-month oral administration of DIM and an additional 12 months with no treatment. The other group will be treated with PDL-only, as a control, and take a placebo pill for 3 months. All of the patients will be followed for a total of 15 months. We will compare lesion recurrence and laboratory tests between the two groups, to determine efficacy and safety of the new treatment. This is the first study to combine new PDL laser technique with DIM, to develop a new, voice-preserving and long-term effective method of managing laryngeal RRP in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 10 to 21 years of age\n2. laryngeal papillomas requiring surgical treatment\n3. willingness to participate in the study\n4. a signed informed consent form by guardian or parent\n\nExclusion Criteria:\n\n1. age less than 10 year old, or older than 21 year\n2. guardian or parent does not understand or can not sign the consent form\n3. malignant diseases such as laryngeal cancer\n4. history of being hypersensitive to cabbage or other cruciferous vegetables\n5. pregnancy'}, 'identificationModule': {'nctId': 'NCT00591305', 'briefTitle': 'New Therapy of Laryngeal Papilloma In Children', 'organization': {'class': 'OTHER', 'fullName': 'Boston University'}, 'officialTitle': 'Voice Preserving Therapy of Laryngeal Papilloma In Children', 'orgStudyIdInfo': {'id': 'RDC-008287A'}, 'secondaryIdInfos': [{'id': '5R01DC008287', 'link': 'https://reporter.nih.gov/quickSearch/5R01DC008287', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PDL+DIM pill', 'description': 'once-time 585 nm pulsed dye laser (PDL) treatment on the lesions, immediately followed by 3-month oral taking diindolylmethane (DIM, at 1.2-1.75mg/kg/day), in 15 subjects', 'interventionNames': ['Dietary Supplement: diindolylmethane (DIM)', 'Device: 585 nm pulsed dye laser']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PDL+placebo pill', 'description': 'once-time PDL treatment on the lesions, then followed by 3-month oral taking DIM placebo, in other 15 subjects', 'interventionNames': ['Device: 585 nm pulsed dye laser']}], 'interventions': [{'name': 'diindolylmethane (DIM)', 'type': 'DIETARY_SUPPLEMENT', 'description': '3-month DIM', 'armGroupLabels': ['PDL+DIM pill']}, {'name': '585 nm pulsed dye laser', 'type': 'DEVICE', 'description': 'once-time PDL', 'armGroupLabels': ['PDL+DIM pill', 'PDL+placebo pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Zhi Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no such meaningful data available due to insufficient recruitment'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Director', 'investigatorFullName': 'Zhi Wang', 'investigatorAffiliation': 'Boston University'}}}}