Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors

This study has been terminated.
(Due to slow accrual)
Sponsor:
Collaborator:
Children's Cancer Research Fund
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01100658
First received: April 7, 2010
Last updated: November 6, 2012
Last verified: November 2012
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Effectiveness of Methylphenidate on Neurocognitive Components [ Time Frame: Week 1 and Week 2 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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
Masonic Cancer Center, University of Minnesota
Children's Cancer Research Fund
Investigators
Principal Investigator: Alicia Kunin-Batson, Ph.D. Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01100658     History of Changes
Other Study ID Numbers: 2009NTLS075, 0907M69644
Study First Received: April 7, 2010
Results First Received: July 28, 2011
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma
Lymphoma, Non-Hodgkin
Acute Disease
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 31, 2014