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Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors

Primary Purpose

ALL, Childhood, Leukemia, Lymphoblastic, Leukemia, Lymphoblastic, Acute

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate
Placebo
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ALL, Childhood

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota Medical Center, Fairview

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Methylphenidate

Placebo

Arm Description

Administered 1 capsule each day for 1 week, .3 mg/kg dose.

Administered 1 capsule each day for 1 week.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 7, 2010
Last Updated
March 16, 2015
Sponsor
University of Minnesota
Collaborators
Children's Cancer Research Fund United States
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1. Study Identification

Unique Protocol Identification Number
NCT01100658
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Due to slow accrual
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Children's Cancer Research Fund United States

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylphenidate
Arm Type
Active Comparator
Arm Description
Administered 1 capsule each day for 1 week, .3 mg/kg dose.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered 1 capsule each day for 1 week.
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Other Intervention Name(s)
Metadae CD (TM), Methylphenidate hydrochloride
Intervention Description
1 capsule each day for 1 week, .3 mg/kg dose.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Inactive substance
Intervention Description
1 capsule per day for 1 week.
Primary Outcome Measure Information:
Title
Effectiveness of Methylphenidate on Neurocognitive Components
Description
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.
Time Frame
Week 1 and Week 2
Secondary Outcome Measure Information:
Title
Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior
Description
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.
Time Frame
Week 1 and Week 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alicia Kunin-Batson, Ph.D.
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Medical Center, Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors

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