Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor
RATIONALE: Modafinil may help improve memory, attention, and fatigue caused by cancer treatment.
PURPOSE: This phase II randomized trial studies how well modafinil works in treating children with memory and attention problems caused by cancer treatment for a brain tumor.
Brain and Central Nervous System Tumors
Psychosocial Effects of Cancer and Its Treatment
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor|
- Change in age-adjusted scores at week six from baseline in any of the 5 questionnaires [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Safety and toxicity of modafinil [ Time Frame: 30 days post intervention ] [ Designated as safety issue: Yes ]
- Improved executive function (apart from working memory) as assessed by BRIEF and CogState [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Reduced fatigue as assessed by PedsQL [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Participants receive modafinil orally (PO) once daily (QD) on days 1-42.
Placebo Comparator: Arm II
Participants receive placebo PO QD on days 1-42.
- Determine whether a 6-week drug trial of modafinil, compared to placebo, is associated with improvement in neurocognitive function as defined by parent report of inattention or working memory deficits or by direct assessment of attention, working memory, or processing speed in children with cognitive impairment after treatment for a primary brain tumor.
- Determine whether modafinil, compared to placebo, is associated with improved executive function (apart from working memory), as assessed using the BRIEF executive function and hippocampal learning and executive function tasks from the CogState battery.
- Determine whether modafinil, compared to placebo, is associated with reduced fatigue as assessed using the PedsQL Multidimensional Fatigue Scale.
- Evaluate the safety of modafinil in this population.
OUTLINE: This is a multicenter study. Participants are randomized to 1 of 2 treatment arms.
- Arm I: Participants receive modafinil orally (PO) once daily (QD) on days 1-42.
- Arm II: Participants receive placebo PO QD on days 1-42. Participants complete a semi-automated, computerized cognitive-testing system (CogState) designed to assess psychomotor, attention/vigilance, memory, and other components of executive function by presenting different tasks, each with its own set of rules, at baseline and after completion of study therapy. Participants also complete the PedsQL Multidimensional Fatigue Scale (Peds QL-MFS).
Parents or legal guardians complete the PedsQL-MFS, the Conners Parent Reported Scale (CPR-3), and the Behavior Rating Inventory of Executive Function (BRIEF) at baseline and after completion of study therapy.
Clinical and/or research staff administer the Systematic Assessment for Treatment Emergency Events (SAFTEE), a semi-structured interview designed to elicit adverse events, at baseline and periodically during study.
After completion of study therapy, participants are followed up for 30 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381718
Show 54 Study Locations
|Study Chair:||Jeffrey P. Krischer, MD, PhD||University of South Florida|
|Study Chair:||Nicole J. Ullrich, MD, PhD||Children's Hospital Boston|