Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT01100658
Status:
TERMINATED
Last Update Posted:
2015-03-27
First Post:
2010-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008774', 'term': 'Methylphenidate'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kunin003@umn.edu', 'phone': '612-624-6931', 'title': 'Alicia Kunin-Batson', 'organization': 'Masonic Cancer Center, University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Only 1 patient was enrolled in this study, no analysis/outcome data can be reported. This patient completed baseline assessment, but withdrew from the study before beginning the medication trial. No medications/placebo were administered.'}}, 'adverseEventsModule': {'description': 'No patients received treatment, therefore no adverse events were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Participant With Attention Deficit', 'description': 'Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effectiveness of Methylphenidate on Neurocognitive Components', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participant With Attention Deficit', 'description': 'Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.'}], 'timeFrame': 'Week 1 and Week 2', 'description': 'Child performance on neuropsychological testing (i.e., using Test of Variables of Attention \\[TOVA\\] which is a computerized test of attention that assists in the screening, diagnosis, and treatment monitoring of attention disorders, like Attention Deficit Hyperactivity Disorder \\[ADHD\\], and working memory index of the WisSC IV. Standard scores average = 100 +/- 15. Higher scores indicate better performance. Scores \\< or = 1 SD below the mean represent area of deficit.', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients received treatment, therefore analysis was not done.', 'anticipatedPostingDate': '2011-07'}, {'type': 'SECONDARY', 'title': 'Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participant With Attention Deficit', 'description': 'Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.'}], 'timeFrame': 'Week 1 and Week 2', 'description': 'Parent and teacher ratings of attention, executive function and behavior (i.e., Behavior Rating Inventory of Executive Function \\[BRIEF -a parent questionnaire and a teacher questionnaire-designed to assess executive functioning in home and school environments. Conners Parent Rating Scale-3 Short Form \\[CPRS-3 research and clinical tool for obtaining parental reports of childhood behavior problems.\\] Standard scores average = 50 + or - 10. Higher scores indicate more severe difficulty. Scores \\> or = 60 represent areas of significant behavior concern.', 'reportingStatus': 'POSTED', 'populationDescription': 'No patients received treatment, therefore analysis was not done.', 'anticipatedPostingDate': '2011-08'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participant With Attention Deficit', 'description': 'Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Only 1 patient was enrolled in this study. This patient completed baseline assessment, but withdrew from the study before beginning the medication trial. No medications/placebo were administered.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participant With Attention Deficit', 'description': 'Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Due to slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-16', 'studyFirstSubmitDate': '2010-04-07', 'resultsFirstSubmitDate': '2011-07-28', 'studyFirstSubmitQcDate': '2010-04-07', 'lastUpdatePostDateStruct': {'date': '2015-03-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-10-11', 'studyFirstPostDateStruct': {'date': '2010-04-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of Methylphenidate on Neurocognitive Components', 'timeFrame': 'Week 1 and Week 2', 'description': 'Child performance on neuropsychological testing (i.e., using Test of Variables of Attention \\[TOVA\\] which is a computerized test of attention that assists in the screening, diagnosis, and treatment monitoring of attention disorders, like Attention Deficit Hyperactivity Disorder \\[ADHD\\], and working memory index of the WisSC IV. Standard scores average = 100 +/- 15. Higher scores indicate better performance. Scores \\< or = 1 SD below the mean represent area of deficit.'}], 'secondaryOutcomes': [{'measure': 'Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior', 'timeFrame': 'Week 1 and Week 2', 'description': 'Parent and teacher ratings of attention, executive function and behavior (i.e., Behavior Rating Inventory of Executive Function \\[BRIEF -a parent questionnaire and a teacher questionnaire-designed to assess executive functioning in home and school environments. Conners Parent Rating Scale-3 Short Form \\[CPRS-3 research and clinical tool for obtaining parental reports of childhood behavior problems.\\] Standard scores average = 50 + or - 10. Higher scores indicate more severe difficulty. Scores \\> or = 60 represent areas of significant behavior concern.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['ALL, Childhood', 'Leukemia, Lymphoblastic', 'Leukemia, Lymphoblastic, Acute', 'Leukemia, Lymphoblastic, Acute, L1', 'Leukemia, Lymphoblastic, Acute, L2', 'Leukemia, Lymphoblastic, Acute, Philadelphia-Positive', 'Leukemia, Lymphocytic, Acute', 'Leukemia, Lymphocytic, Acute, L1', 'Leukemia, Lymphocytic, Acute, L2', 'Lymphoblastic Leukemia', 'Lymphoblastic Leukemia, Acute', 'Lymphoblastic Leukemia, Acute, Childhood', 'Lymphoblastic Leukemia, Acute, L1', 'Lymphoblastic Leukemia, Acute, L2', 'Lymphoblastic Lymphoma', 'Lymphocytic Leukemia, Acute', 'Lymphocytic Leukemia, L1', 'Lymphocytic Leukemia, L2', 'Brain Tumors', 'Cancer of the Brain', 'Cancer of Brain', 'Malignant Primary Brain Tumors', 'Brain Neoplasms, Malignant']}, 'descriptionModule': {'briefSummary': 'While neurocognitive impairments in attention, memory and executive functioning are commonly reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to examine the treatment of attention deficits in this population. Numerous studies have examined the effectiveness of methylphenidate in the treatment of children with attention deficit hyperactivity disorder (ADHD). However, the effectiveness of this medication for improving attention and behavioral functioning in children with medical illnesses or brain injury are less clear.\n\nPatients will be randomized to receive one week of Metadate CD (a controlled release form of methylphenidate, similar to Ritalin) and one week of placebo in a double-blind fashion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInitial Screening and Registration\n\n* Previous diagnosis of acute lymphoblastic leukemia or brain tumor and have been off treatment and in disease-free remission for a minimum of one year; treated at the University of Minnesota Medical Center, Fairview.\n* Proficient in English\n* Have given informed consent (assent)\n\nAfter Initial Screening\n\n* Have evidence of attention impairment based on parent report of attention deficit (\\> and = 75% on attention deficit hyperactivity disorder \\[ADHD\\] Index, Hyperactivity, or Cognitive-Problems/Inattention Index of parent-completed attention deficit hyperactivity disorder (ADHD) rating scale \\[Conners Parent Rating Scale\\] and perform at least 1.0 standard deviations below the mean on Omissions, Commissions, or Variability indexes of the Test of Variables of Attention (TOVA)\n* Have an estimated Full Scale IQ score on the Wechsler Abbreviated Scale of Intelligence (WASI) \\>55.\n\nExclusion Criteria:\n\n* Have optic pathway gliomas and/or neurofibromatosis\n* Diagnosed with ADD/ADHD prior to their cancer diagnosis\n* Currently taking antidepressants or antipsychotics\n* Currently being treated with stimulant medication\n* Blind\n* Have glaucoma\n* Have a family or personal history of motor or phonic tics or Tourette syndrome\n* Have seizures not controlled by antiepileptic drugs\n* Taking an MAO-inhibitor\n* Have a history of cardiovascular disease, uncontrolled hypertension, or hyperthyroidism, or current hypertension requiring antihypertensives'}, 'identificationModule': {'nctId': 'NCT01100658', 'briefTitle': 'Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Effects of Methylphenidate on Neuropsychological Functioning in Children With Attention Deficits Secondary to Childhood Cancer', 'orgStudyIdInfo': {'id': '2009NTLS075'}, 'secondaryIdInfos': [{'id': '0907M69644', 'type': 'OTHER', 'domain': 'IRB, University of Minnesota'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methylphenidate', 'description': 'Administered 1 capsule each day for 1 week, .3 mg/kg dose.', 'interventionNames': ['Drug: Methylphenidate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Administered 1 capsule each day for 1 week.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Methylphenidate', 'type': 'DRUG', 'otherNames': ['Metadae CD (TM)', 'Methylphenidate hydrochloride'], 'description': '1 capsule each day for 1 week, .3 mg/kg dose.', 'armGroupLabels': ['Methylphenidate']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Inactive substance'], 'description': '1 capsule per day for 1 week.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Medical Center, Fairview', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Alicia Kunin-Batson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masonic Cancer Center, University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Cancer Research Fund", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}