Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor
Condition: Brain and Central Nervous System Tumors; Cognitive/Functional Effects; Fatigue; Neurotoxicity; Psychosocial Effects of Cancer and Its Treatment
MeSH terms: Brain Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Neurotoxicity Syndromes; Fatigue
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): modafinil; placebo
Intervention type(s): Drug; Other
Intervention description(s): Given PO; Given PO
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: childhood brain tumor; neurotoxicity; fatigue; cognitive/functional effects; psychosocial effects of cancer and its treatment