Clinical trial NCT01100658: Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors
Official title: Effects of Methylphenidate on Neuropsychological Functioning in Children With Attention Deficits Secondary to Childhood Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Children's Cancer Research Fund
First posted: 2010-04-09
Enrollment: 1
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of Methylphenidate on Neurocognitive Components
timeFrame: Week 1 and Week 2
Secondary outcomes:
measure: Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior
timeFrame: Week 1 and Week 2
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center, Fairview
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Alicia Kunin-Batson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: