Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors
This study has been terminated.
(Due to slow accrual)
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Collaborator:
Children's Cancer Research Fund United States
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01100658
First received: April 7, 2010
Last updated: August 21, 2014
Last verified: August 2014
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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:
Genetic and Rare Diseases Information Center resources:
Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia, Childhood
Lymphoblastic Lymphoma
Lymphosarcoma
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 ] [ 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:
|
|
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
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
No publications provided
| Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
| 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: | August 21, 2014 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Acute Disease Brain Neoplasms Leukemia Leukemia, Lymphoid Neoplasms Precursor Cell Lymphoblastic Leukemia-Lymphoma Brain Diseases Central Nervous System Diseases Central Nervous System Neoplasms Disease Attributes Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms by Histologic Type |
Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pathologic Processes Methylphenidate Central Nervous System Agents Central Nervous System Stimulants Dopamine Agents Dopamine Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015