Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT03489551
Status:
COMPLETED
Last Update Posted:
2018-05-22
First Post:
2018-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006220', 'term': 'Haloperidol'}], 'ancestors': [{'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michelle-weckmann@uiowa.edu', 'phone': '319-384-7538', 'title': 'Michelle Weckmann', 'organization': 'University of Iowa'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Oral Haldol in Patients Undergoing HSCT', 'description': 'Prior to stem cell transplant participants will receive 5mg of liquid or pill form, oral Haldol. Every other day visits will take place following the first administration of the study drug until 14 days after the transplant.\n\nHaldol', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Excessive sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Side Effects and Tolerability of Haldol in Patients With Undergoing Hematopoietic Stem Cell Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Haldol in Patients Undergoing HSCT', 'description': 'Prior to stem cell transplant participants will receive 5mg of liquid or pill form, oral Haldol. Every other day visits will take place following the first administration of the study drug until 14 days after the transplant.\n\nHaldol'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Daily, up to 14 days following transplant', 'description': 'Categorize and quantify adverse events from start of drug (day 1) to end of study drug per (CTCAE) version 4.0', 'unitOfMeasure': 'Adverse Event', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Haldol in Patients Undergoing HSCT', 'description': 'Prior to stem cell transplant participants will receive 5mg of liquid or pill form, oral Haldol. Every other day visits will take place following the first administration of the study drug until 14 days after the transplant.\n\nHaldol'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Haldol in Patients Undergoing HSCT', 'description': 'Prior to stem cell transplant participants will receive 5mg of liquid or pill form, oral Haldol. Every other day visits will take place following the first administration of the study drug until 14 days after the transplant.\n\nHaldol'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'groupId': 'BG000', 'lowerLimit': '46.8', 'upperLimit': '70.7'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '15 participants completed treatment'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-22', 'studyFirstSubmitDate': '2018-03-29', 'resultsFirstSubmitDate': '2018-04-22', 'studyFirstSubmitQcDate': '2018-03-29', 'lastUpdatePostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-22', 'studyFirstPostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Side Effects and Tolerability of Haldol in Patients With Undergoing Hematopoietic Stem Cell Transplant', 'timeFrame': 'Daily, up to 14 days following transplant', 'description': 'Categorize and quantify adverse events from start of drug (day 1) to end of study drug per (CTCAE) version 4.0'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stem Cell Transplant Complications', 'Delirium']}, 'descriptionModule': {'briefSummary': 'This research study proposes to conduct an open label, feasibility study administering prophylactic oral haldol to patients undergoing a hematopoietic stem cell transplant (HSCT).\n\nThe study will address the following research aims: 1) To demonstrate the feasibility of enrolling HSCT patients in a prophylactic medication trial, 2) To determine the tolerability of oral haldol in HSCT patients and 2) To compare rates of delirium in HSCT patients who receive prophylactic haldol with an untreated historical control group.', 'detailedDescription': 'This is an open label, safety \\& feasibility, clinical drug trial. We will use historical controls from previous research with bone marrow transplant patients and delirium incidence at University of Iowa Hospitals and Clinics (UIHC) to evaluate the efficacy of prophylactic Haldol in the prevention of delirium. This study will recruit adult cancer patients undergoing hematopoietic stem cell transplant (HSCT) at UIHC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participant must undergo an autologous or allogeneic bone marrow or stem cell transplant\n* The participant is 18 years of age or older\n* The participant provides written consent\n\nExclusion Criteria:\n\n* The participant has a QTc of \\>450 msec at the time of enrollment\n* The participant used any antipsychotic medications within the last 30 days\n* The participant has any significant allergies or past intolerance to Haloperidol\n* The participant has a history of major neurological, metabolic, psychiatric, or cardiovascular disease, cerebrovascular event, or substance abuse\n* The participant has a history of mental retardation or learning disability that, at the discretion of the investigator, could affect their ability to complete study assessments.'}, 'identificationModule': {'nctId': 'NCT03489551', 'acronym': 'PHDC', 'briefTitle': 'Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients', 'orgStudyIdInfo': {'id': '201107736'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Haldol in patients undergoing HSCT', 'description': 'Prior to stem cell transplant participants will receive 5mg of liquid or pill form, oral Haldol. Every other day visits will take place following the first administration of the study drug until 14 days after the transplant.', 'interventionNames': ['Drug: Haldol']}], 'interventions': [{'name': 'Haldol', 'type': 'DRUG', 'otherNames': ['haloperidol'], 'armGroupLabels': ['Oral Haldol in patients undergoing HSCT']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michelle Weckmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michelle Weckmann', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Michelle Weckmann', 'investigatorAffiliation': 'University of Iowa'}}}}