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
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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 |
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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 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 |

Arm | Intervention/treatment |
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Active Comparator: Methylphenidate
Administered 1 capsule each day for 1 week, .3 mg/kg dose.
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Drug: Methylphenidate
1 capsule each day for 1 week, .3 mg/kg dose.
Other Names:
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Placebo Comparator: Placebo
Administered 1 capsule each day for 1 week.
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Drug: Placebo
1 capsule per day for 1 week.
Other Name: Inactive substance |
- 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.
- 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.

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Ages Eligible for Study: | 8 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts 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

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
United States, Minnesota | |
University of Minnesota Medical Center, Fairview | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Alicia Kunin-Batson, Ph.D. | Masonic Cancer Center, University of Minnesota |
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 |
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 |