Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor
- Conditions
- Brain and Central Nervous System TumorsCognitive/Functional EffectsFatigueNeurotoxicityPsychosocial Effects of Cancer and Its Treatment
- Interventions
- Other: placeboDrug: modafinil
- Registration Number
- NCT01381718
- Lead Sponsor
- University of South Florida
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* Determine whether a 6-week drug trial of modafinil, compared to placebo, is associated with improvement in neurocognitive function as defined by direct assessment of attention in children with cognitive impairment after treatment for a primary brain tumor.
Secondary
* Determine whether modafinil, compared to placebo, is associated with improved executive function, 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 improved attention, as assessed by the Conners' (3rd Edition) 3 Parent Rating Scale (CPRS-3) - Short Form.
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II placebo Participants receive placebo PO QD on days 1-42. Arm I modafinil Participants receive modafinil orally (PO) once daily (QD) on days 1-42.
- Primary Outcome Measures
Name Time Method Change in Age-Adjusted Scores at Week Six From Baseline in the Attention Task of the CogState Battery Baseline and 6 weeks CogState Battery. CogState is a semi-automated, computerized cognitive testing system that was developed as a rapid and accurate test of cognitive function specifically for repeated assessment that is sensitive to the effects of medication in children over the age of 5 years and in adults from different language, cultural and socio-economic backgrounds. The CogState tasks to assess processing speed, visual attention, working memory and executive function were used. The CogState battery was administered in the following order: Detection Task, Identification Task, One Card Learning Task, One Back Task, and lastly, the Modified Groton Maze Learning Task. It was administered at baseline and 6 weeks. A positive change from baseline is an improvement. There is not a minimum or maximum since the value is reported as a z-score, but with the mean = 0 and the SD = 1, the range should be between -3 and 3.
- Secondary Outcome Measures
Name Time Method Number of Reported Adverse Events (AEs) 30 days post intervention AEs gathered using SAFTEE (Systematic Assessment for Treatment Emergent Effects) and participant report on daily log.
Change in Working Memory Score at 6 Weeks From Baseline as Assessed on BRIEF Baseline and 6 weeks Behavior Rating Inventory of Executive Function (BRIEF). The BRIEF is a behavior rating scale designed to assess executive functions in the home and school environments. The measure was selected to provide parent-reported outcomes of problems related to attention, memory and executive function that occur in everyday life. The instrument was utilized to measure the change in working memory, according to the parent's perspective only, from baseline to 6 weeks. Scores are linear transformations of raw scores into T scores (mean = 50, SD = 10); higher scores indicate greater difficulties. The baseline score was subtracted from the 6 week score. Positive change from baseline is an improvement. The total scale ranges from 0 to 172. A T score \>60 on the BRIEF working memory subscale indicates cognitive impairment.
Change in PedsQL Score at 6 Weeks From Baseline Baseline and 6 weeks PedsQL is Pediatric Quality of Life Inventory Multi-dimensional Fatigue Scale. This scale is designed as a generic symptom-specific instrument to measure fatigue. Higher scores indicate fewer symptoms of fatigue. It was administered at baseline and 6 weeks. The score is the sum of the answers. The baseline score was subtracted from the 6 week score. A positive change indicates worsening. The scale total score range is from 0-72 for both the parent and patient reported instruments.
Trial Locations
- Locations (60)
A. I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Lucile Packard Children's Hospital Stanford University
🇺🇸Palo Alto, California, United States
Joe DiMaggio Children's Hospital
🇺🇸Hollywood, Florida, United States
Nemours Children's Clinic- Pensacola
🇺🇸Pensacola, Florida, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Lee Memorial Health System
🇺🇸Fort Myers, Florida, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Miller Children's Hospital
🇺🇸Long Beach, California, United States
All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
East Tennessee Children's Hospital
🇺🇸Knoxville, Tennessee, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
St. Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Saint Louis University Cancer Center
🇺🇸Saint Louis, Missouri, United States
Children's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
Riley Hospital for Children- Indiana University
🇺🇸Indianapolis, Indiana, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Rady Children's Hospital - San Diego
🇺🇸San Diego, California, United States
Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
University of Mississippi
🇺🇸Jackson, Mississippi, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Dayton Children's Hospital
🇺🇸Dayton, Ohio, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
🇺🇸New York, New York, United States
Children's Hospital of Colorado; Saint Joseph Hospital
🇺🇸Denver, Colorado, United States
CS Mott/University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Doernbecher Children's Hospital/ Oregoon Health Science University
🇺🇸Portland, Oregon, United States
Vanderbilt Children's Hospital
🇺🇸Nashville, Tennessee, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
SunCoast CCOP Research Base at the University of South Florida
🇺🇸Tampa, Florida, United States
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
St. Luke's Mountain States Tumor Institute
🇺🇸Boise, Idaho, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Children's Hospitals and Clinics of Minnesota
🇺🇸Minneapolis, Minnesota, United States
New York University Langone Medical Center
🇺🇸New York, New York, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Saint Louis University / Cardinal Glennon Children's Medical Center
🇺🇸Saint Louis, Missouri, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Nemours Children's Hospital
🇺🇸Orlando, Florida, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
Children's Mercy Hospital and Clinics
🇺🇸Kansas City, Missouri, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States