Title
Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors
Effects of Methylphenidate on Neuropsychological Functioning in Children With Attention Deficits Secondary to Childhood Cancer
Phase
N/ALead Sponsor
University of MinnesotaStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Brain Tumors 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 Cancer of the Brain Cancer of Brain Malignant Primary Brain Tumors Brain Neoplasms, MalignantIntervention/Treatment
methylphenidate ...Study Participants
1While 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.
1 capsule each day for 1 week, .3 mg/kg dose.
1 capsule per day for 1 week.
Administered 1 capsule each day for 1 week, .3 mg/kg dose.
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
| Event Type | Organ System | Event Term |
|---|
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.
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.
