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| ID | Type | Description | Link |
|---|---|---|---|
| 0907M69644 | Other Identifier | IRB, University of Minnesota |
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Due to slow accrual
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| Name | Class |
|---|---|
| Children's Cancer Research Fund | OTHER |
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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.
Patients 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate | Active Comparator | Administered 1 capsule each day for 1 week, .3 mg/kg dose. |
|
| Placebo | Placebo Comparator | Administered 1 capsule each day for 1 week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate | Drug | 1 capsule each day for 1 week, .3 mg/kg dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Methylphenidate on Neurocognitive Components | 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. | Week 1 and Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior | 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.](streamdown:incomplete-link) |
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Inclusion Criteria:
Initial Screening and Registration
After Initial Screening
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alicia Kunin-Batson, Ph.D. | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota | 55455 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participant With Attention Deficit | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | 1 capsule per day for 1 week. |
|
|
| Week 1 and Week 2 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participant With Attention Deficit | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effectiveness of Methylphenidate on Neurocognitive Components | 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. | No patients received treatment, therefore analysis was not done. | Posted | Jul 2011 | Week 1 and Week 2 |
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| ||||||||||||||||||
| Secondary | Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior | 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.](streamdown:incomplete-link) | No patients received treatment, therefore analysis was not done. | Posted | Aug 2011 | Week 1 and Week 2 |
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No patients received treatment, therefore no adverse events were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participant With Attention Deficit | 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. | 0 | 0 | 0 | 0 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alicia Kunin-Batson | Masonic Cancer Center, University of Minnesota | 612-624-6931 | kunin003@umn.edu |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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