Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
Study NCT ID:
NCT04128267
Status:
TERMINATED
Last Update Posted:
2022-09-19
First Post:
2019-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Central Pain Syndrome in Survivors of Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'teresa.melton@vumc.org', 'phone': '(615) 936-7423', 'title': 'Teresa Melton', 'organization': 'Vanderbilt-Ingram Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From date of enrollment until 30 days after completing last study intervention, on average of 3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Response to Pain', 'description': "Brain's response to pain using magnetic resonance imaging (MRI)\n\nIPC-1000: Delivers pressure to thumbnail for five seconds at a time\n\nMagnetic resonance imaging: Scan of brain using Magnetic resonance imaging\n\nCorrelative Studies: Administration of questionnaires via computer", 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 3, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Magnetic Resonance Imaging (MRI) to Correlate With One of Three Pain Phenotypes 1) no Pain, 2) Central Pain, 3) Nociceptive Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Response to Pain', 'description': "Brain's response to pain using magnetic resonance imaging (MRI)\n\nIPC-1000: Delivers pressure to thumbnail for five seconds at a time\n\nMagnetic resonance imaging: Scan of brain using Magnetic resonance imaging\n\nCorrelative Studies: Administration of questionnaires via computer"}], 'timeFrame': 'Approximately 8 weeks', 'description': 'MRI scan of brain to measure response to stimulated pressure to thumbnail', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected due to the technical issues.'}, {'type': 'PRIMARY', 'title': 'Magnetic Resonance Imaging (MRI) to Correlate Presence of Chronic Systemic Symptoms With Pain Phenotype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Response to Pain', 'description': "Brain's response to pain using magnetic resonance imaging (MRI)\n\nIPC-1000: Delivers pressure to thumbnail for five seconds at a time\n\nMagnetic resonance imaging: Scan of brain using Magnetic resonance imaging\n\nCorrelative Studies: Administration of questionnaires via computer"}], 'timeFrame': 'Approximately 8 weeks', 'description': 'MRI scan of brain to measure response to stimulated pressure to thumbnail', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected due to the technical issues.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Response to Pain', 'description': "Brain's response to pain using magnetic resonance imaging (MRI)\n\nIPC-1000: Delivers pressure to thumbnail for five seconds at a time\n\nMagnetic resonance imaging: Scan of brain using Magnetic resonance imaging\n\nCorrelative Studies: Administration of questionnaires via computer"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Participant had other medical issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Participant failed to respond to multiple attempts to contact', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This study enrolled participants at Vanderbilt University Medical Center from November 4, 2019 to July 21, 2022. The study stopped early due to low accrual and technical issues with equipment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Response to Pain', 'description': "Brain's response to pain using magnetic resonance imaging (MRI)\n\nIPC-1000: Delivers pressure to thumbnail for five seconds at a time\n\nMagnetic resonance imaging: Scan of brain using Magnetic resonance imaging\n\nCorrelative Studies: Administration of questionnaires via computer"}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-31', 'size': 343649, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-28T11:06', 'hasProtocol': True}, {'date': '2021-06-30', 'size': 380423, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-03-02T14:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'whyStopped': 'Recruitment/accrual impacted by COVID and technical issues with equipment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2019-10-14', 'resultsFirstSubmitDate': '2022-07-28', 'studyFirstSubmitQcDate': '2019-10-14', 'lastUpdatePostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-23', 'studyFirstPostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnetic Resonance Imaging (MRI) to Correlate With One of Three Pain Phenotypes 1) no Pain, 2) Central Pain, 3) Nociceptive Pain', 'timeFrame': 'Approximately 8 weeks', 'description': 'MRI scan of brain to measure response to stimulated pressure to thumbnail'}, {'measure': 'Magnetic Resonance Imaging (MRI) to Correlate Presence of Chronic Systemic Symptoms With Pain Phenotype', 'timeFrame': 'Approximately 8 weeks', 'description': 'MRI scan of brain to measure response to stimulated pressure to thumbnail'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'This is a cross-sectional pilot study of head and neck cancer survivors who have completed multi-modal treatment to assess and characterize the presence of distinct pain syndromes.', 'detailedDescription': 'Primary objectives:\n\n* To correlate structural and functional MRI signature with one of three pain phenotypes in head and neck cancer survivors: 1) no pain, 2) central pain, and 3) nociceptive pain.\n* To correlate the presence of chronic systemic symptoms with pain phenotype\n\nExploratory objectives:\n\n\\- DNA, RNA, and plasma will be collected for genomic, transcriptomic, and proteomic studies. Results will be vertically integrated along with the results of clinical studies described within this protocol to identify targets for future correlative studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically proven head and neck cancer\n* Patients without a diagnosis of head and neck cancer (up to 10 patients, see below)\n\n * We anticipate enrolling a total of 75 patients with a history of head and neck cancer who will complete all questionnaires and MRI scanning. We will also recruit up to 10 patients WITHOUT a diagnosis of head and neck cancer to facilitate optimization of the MRI scanning processes. This will allow us to address logistical issues, such as pressure stimulator setup and timing of each scan to be performed.\n* Completed multi-modality therapy a minimum of 6 weeks prior to study entry.\n* Willing and able to provide informed consent\n* All participants must be at least 21 years of age\n* Able to speak English\n\nExclusion Criteria:\n\n* Patients who are pregnant\n* Patients who are unable to lie still\n* Patients who are unable tolerate pressure stimulator\n* Non-MRI compatible devices such as aneurysm clips, cardiac pacemakers or defibrillators, cochlear implants, hardware, or any other implants\n* Iron-based tattoos, pieces of metal (bullet, BB, shrapnel) close to or in an important organ (such as the eye), or other non-MRI compatible metal in the body'}, 'identificationModule': {'nctId': 'NCT04128267', 'briefTitle': 'Central Pain Syndrome in Survivors of Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Characterization of Central Pain Syndrome in Survivors of Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'VICC HN 1982'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Response to Pain', 'description': "Brain's response to pain using magnetic resonance imaging (MRI)", 'interventionNames': ['Device: IPC-1000', 'Device: Magnetic resonance imaging', 'Other: Correlative Studies']}], 'interventions': [{'name': 'IPC-1000', 'type': 'DEVICE', 'description': 'Delivers pressure to thumbnail for five seconds at a time', 'armGroupLabels': ['Response to Pain']}, {'name': 'Magnetic resonance imaging', 'type': 'DEVICE', 'description': 'Scan of brain using Magnetic resonance imaging', 'armGroupLabels': ['Response to Pain']}, {'name': 'Correlative Studies', 'type': 'OTHER', 'description': 'Administration of questionnaires via computer', 'armGroupLabels': ['Response to Pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Dianne Lou, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dianne Lou', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}