Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors - Full Text View

Purpose

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	Intervention
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

Condition

Intervention

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment
Official Title:	Effects of Methylphenidate on Neuropsychological Functioning in Children With Attention Deficits Secondary to Childhood Cancer

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Acute Lymphoblastic Leukemia Childhood Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:

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:

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.


Enrollment:	1
Study Start Date:	May 2010
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100658

Locations


United States, Minnesota
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

Children's Cancer Research Fund United States

Investigators


Principal Investigator:	Alicia Kunin-Batson, Ph.D.	Masonic Cancer Center, University of Minnesota

More Information


Responsible Party:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT01100658 History of Changes
Other Study ID Numbers:	2009NTLS075 0907M69644 ( Other Identifier: IRB, University of Minnesota )
Study First Received:	April 7, 2010
Results First Received:	July 28, 2011
Last Updated:	March 16, 2015

Additional relevant MeSH terms:


Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Attention Deficit Disorder with Hyperactivity Brain Neoplasms Acute Disease Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders	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

Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Attention Deficit Disorder with Hyperactivity
Brain Neoplasms
Acute Disease
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders

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

ClinicalTrials.gov processed this record on July 26, 2017