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Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors

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ClinicalTrials.gov Identifier: NCT01100658
Recruitment Status : Terminated (Due to slow accrual)
First Posted : April 9, 2010
Results First Posted : November 22, 2011
Last Update Posted : March 27, 2015
Sponsor:
Collaborator:
Children's Cancer Research Fund United States
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.


Condition or disease Intervention/treatment Phase
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 Drug: Methylphenidate Drug: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Methylphenidate on Neuropsychological Functioning in Children With Attention Deficits Secondary to Childhood Cancer
Study Start Date : May 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Methylphenidate
Administered 1 capsule each day for 1 week, .3 mg/kg dose.
 Drug: Methylphenidate
1 capsule each day for 1 week, .3 mg/kg dose.
Other Names:
  • Metadae CD (TM)
  • Methylphenidate hydrochloride
Placebo Comparator: Placebo
Administered 1 capsule each day for 1 week.
 Drug: Placebo
1 capsule per day for 1 week.
Other Name: Inactive substance


Outcome Measures
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Primary Outcome Measures :
  1. Effectiveness of Methylphenidate on Neurocognitive Components [ Time Frame: 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 Outcome Measures :
  1. Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100658


Locations
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United States, Minnesota
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Children's Cancer Research Fund United States
Investigators
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Principal Investigator: Alicia Kunin-Batson, Ph.D. Masonic Cancer Center, University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01100658    
Other Study ID Numbers: 2009NTLS075
0907M69644 ( Other Identifier: IRB, University of Minnesota )
First Posted: April 9, 2010    Key Record Dates
Results First Posted: November 22, 2011
Last Update Posted: March 27, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Neoplasms
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Brain Neoplasms
Acute Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Disease Attributes
Pathologic Processes
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents