Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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|
|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 (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effects of Methylphenidate on Neuropsychological Functioning in Children With Attention Deficits Secondary to Childhood Cancer|
|Study Start Date :||May 2010|
|Primary Completion Date :||November 2010|
|Study Completion Date :||November 2010|
Active Comparator: Methylphenidate
Administered 1 capsule each day for 1 week, .3 mg/kg dose.
1 capsule each day for 1 week, .3 mg/kg dose.
Placebo Comparator: Placebo
Administered 1 capsule each day for 1 week.
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.
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|