Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors

Brain Tumors Clinical Trial

Official title:

Effects of Methylphenidate on Neuropsychological Functioning in Children With Attention Deficits Secondary to Childhood Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01100658
• Other study ID #: 2009NTLS075
• Secondary ID: 0907M69644
• Status: Terminated
• Phase: N/A
• First received: April 7, 2010
• Last updated: March 16, 2015
• Start date: May 2010
• Est. completion date: November 2010

Study information

• Verified date: March 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Disease
• ALL, Childhood
• Attention Deficit Disorder with Hyperactivity
• Brain Neoplasms
• Brain Neoplasms, Malignant
• Brain Tumors
• Cancer of Brain
• Cancer of the Brain
• Leukemia
• 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
• Leukemia, Lymphoid
• 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
• Neoplasms
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Methylphenidate
1 capsule each day for 1 week, .3 mg/kg dose.
• Placebo
1 capsule per day for 1 week.

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center, Fairview	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Children's Cancer Research Fund United States

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Week 1 and Week 2	No
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.	Week 1 and Week 2	No