ALL, Childhood, Brain Neoplasms, Malignant, Brain Tumors, Cancer of Brain, Cancer of the Brain, 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, Malignant Primary Brain Tumors
Conditions
Brief summary
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.
Interventions
DRUGMethylphenidate
1 capsule each day for 1 week, .3 mg/kg dose.
DRUGPlacebo
1 capsule per day for 1 week.
Sponsors
Children's Cancer Research Fund
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Initial Screening and Registration * 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. * Proficient in English * Have given informed consent (assent) After Initial Screening * 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) * Have an estimated Full Scale IQ score on the Wechsler Abbreviated Scale of Intelligence (WASI) \>55.
Exclusion criteria
* Have optic pathway gliomas and/or neurofibromatosis * Diagnosed with ADD/ADHD prior to their cancer diagnosis * Currently taking antidepressants or antipsychotics * Currently being treated with stimulant medication * Blind * Have glaucoma * Have a family or personal history of motor or phonic tics or Tourette syndrome * Have seizures not controlled by antiepileptic drugs * Taking an MAO-inhibitor * Have a history of cardiovascular disease, uncontrolled hypertension, or hyperthyroidism, or current hypertension requiring antihypertensives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Methylphenidate on Neurocognitive Components | Week 1 and Week 2 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior | Week 1 and Week 2 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Participant With Attention Deficit |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Week 1 and Week 2
Population: No patients received treatment, therefore analysis was not done.
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.
Time frame: Week 1 and Week 2
Population: No patients received treatment, therefore analysis was not done.