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Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor

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ClinicalTrials.gov Identifier: NCT01381718
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

June 23, 2011
June 27, 2011
October 27, 2017
August 2011
August 2016   (Final data collection date for primary outcome measure)
Change in age-adjusted scores at week six from baseline in the attention task of the CogState battery [ Time Frame: 6 weeks ]
Change in age-adjusted scores at week six from baseline in any of the 5 questionnaires
Complete list of historical versions of study NCT01381718 on ClinicalTrials.gov Archive Site
  • Safety and toxicity of modafinil [ Time Frame: 30 days post intervention ]
  • Improved executive function (apart from working memory) as assessed by BRIEF and CogState [ Time Frame: 6 weeks ]
  • Reduced fatigue as assessed by PedsQL [ Time Frame: 6 weeks ]
  • Safety and toxicity of modafinil
  • Improved executive function (apart from working memory) as assessed by BRIEF and CogState
  • Reduced fatigue as assessed by PedsQL
Not Provided
Not Provided
 
Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor
A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary 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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Brain and Central Nervous System Tumors
  • Cognitive/Functional Effects
  • Fatigue
  • Neurotoxicity
  • Psychosocial Effects of Cancer and Its Treatment
  • Drug: modafinil
    Given PO
  • Other: placebo
    Given PO
  • Experimental: Arm I
    Participants receive modafinil orally (PO) once daily (QD) on days 1-42.
    Intervention: Drug: modafinil
  • Placebo Comparator: Arm II
    Participants receive placebo PO QD on days 1-42.
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
August 2016
August 2016   (Final data collection date for primary outcome measure)

INCLUSION CRITERIA:

  • Age ≥ 6 years and ≤ 18 years 10 months at the time of study entry (so that participants will be < 19 at the 6 week evaluation, which is the upper age limit for which the included instruments are valid).
  • Diagnosis of a primary brain tumor treated with at least one of the following:

    1. neurosurgical resection of the brain tumor;
    2. cranial irradiation; or
    3. any chemotherapy to treat the brain tumor.
  • Off-treatment and progression-free for at least 12 months and ≤ 14 years. Treatment cessation is defined as the final dose of chemotherapy, the last dose (fraction) of radiation or date of surgery, whichever occurred last.
  • Parent/Legal Guardian and child able to read English or Spanish.
  • Vision and hearing (eyeglasses and/or hearing aid permissible) sufficient for valid test administration and cooperation with examinations.
  • Availability of a reliable parent or legal guardian who is willing and able to complete all of the outcome measures and fulfill the requirements of the study, including administration of medications and accompanying the participant to all study visits.
  • Females of childbearing potential must have a negative pregnancy test result and must agree to use a medically acceptable method of contraception throughout the entire study period and for 30 days after the last dose of study drug.
  • Childbearing potential is defined as girls who are >Tanner stage 2, except for those who have documented pan pituitary insufficiency or other hormonal state incompatible with pregnancy.
  • Urine pregnancy tests are acceptable.

EXCLUSION CRITERIA:

  • Off treatment > 14 years
  • Inability to perform the testing procedure (for example, because of aphasia, motor deficits affecting the dominant hand, or IQ < 70)
  • Known cardiac disorders including arrhythmias, hypertension requiring treatment or structural heart disease
  • Diagnosis of narcolepsy, sick sinus syndrome, arrhythmia or prolonged QTc
  • History of stroke or head injury associated with loss of consciousness within 12 months of registration
  • History of grade 2 depression or anxiety or treatment with antidepressants, antipsychotics or MAO inhibitors within 30 days of registration
  • Concurrent treatment with any medications or substances that are potent inhibitors or inducers of CYP3A4, hepatic enzyme inducing antiepileptic drugs (EIAEDs),or other drugs known to affect the metabolism of modafinil. Examples include but are not limited to itraconazole, ketoconazole, doxycycline, rifampin, St. John's wort, phenytoin, phenobarbital, diazepam, tricyclic antidepressants.
  • If patients were previously taking, EIAEDs, they must be off for > 2 weeks prior to study enrollment.
  • Treatment with other stimulant medications within 14 days of registration; however, a diagnosis of ADHD does NOT exclude a child from participation
  • Participants with known hypersensitivity to modafinil, armodafinil or any of its components
Sexes Eligible for Study: All
6 Years to 19 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
Canada
 
NCT01381718
SCUSF 0901
SCUSF-0901 ( Other Identifier: SunCoast CCOP Research Base )
ACCL0922 ( Other Identifier: Children's Oncology Network )
5U10CA081920-11 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of South Florida
University of South Florida
National Cancer Institute (NCI)
Study Chair: Jeffrey P. Krischer, MD, PhD University of South Florida
Study Chair: Nicole J. Ullrich, MD, PhD Boston Children’s Hospital
University of South Florida
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP