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This multicenter trial investigates how well modafinil works in treating children with memory and attention problems caused by cancer treatment for a brain tumor. Neurocognitive dysfunction (difficulty thinking and learning) affects nearly half of all childhood cancer survivors, especially children treated for a brain tumor. Modafinil is a stimulant medicine that has been studied in children with attention deficit disorder and excessive sleepiness, has shown good results for improving cognition, mood, and fatigue in adult breast cancer and brain tumor survivors.
Subject to certain exclusion criteria, this study is open to males and females, ages 6 to 19 years, who have been treated for brain cancer by neurosurgical resection, cranial irradiation or chemotherapy. A screening process will determine whether candidates have experienced neurocognitive changes after treatment for cancer.
Males and Females: Ages 6 to 18 years
Study participants will be randomly assigned to one of two groups. One will be given a placebo and the other will receive the study drug taken orally for 6 weeks. During the study, participants will be tested for attention, memory, and speed of cognitive processing. Clinic visits are required for screening and after 2 weeks and 6 weeks on the study medication, and telephone interviews will take place during the other weeks. The final visit or telephone contact will occur a month after the final dose is taken.
Visits: 3 or 4
Duration: 10 weeks
Children’s Oncology Group (ACCL0922)
National Cancer Institute
SunCoast CCOP Research Base
Study Description at National Institutes of Health
Cancer and Blood Disorder Research
Jean M. Tersak, MD
For more information about the study or enrollment, please contact:
Jean M. Tersak, MD
Children's Hospital's main campus is located in the Lawrenceville neighborhood. Our main hospital address is:
UPMC Children’s Hospital of Pittsburgh
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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