Reducing fatigue, depression, and cognitive deficits with modafinil in low-grade glioma patients.
Completed
- Conditions
- fatigue, depression, cognition in low-grade glioma patients
- Registration Number
- NL-OMON25601
- Lead Sponsor
- Department of neurologyVU University Medical CenterP.O. Box 70571007 MB Amsterdam
- Brief Summary
Boele, Florien W., et al. "The effect of modafinil on fatigue, cognitive functioning, and mood in primary brain tumor patients: a multicenter randomized controlled trial." Neuro-oncology 15.10 (2013): 1420-1428.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 64
Inclusion Criteria
1. Reported severe fatigue (score > 35) on the Checklist Individual Strength (CIS)[51];
2. Histologically proven LGG without signs of tumor recurrence in the last year;
Exclusion Criteria
1. History of chemotherapy treatment;
2. Anti-tumor treatment other than antiepileptic drugs (e.g. chemotherapy, radiotherapy, corticosteroids);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study parameters are scores on the CIS, MOS, SF-36, BCM and neuropsychological assessment on the three assessment moments.
- Secondary Outcome Measures
Name Time Method Secondary study parameter is synchronization likelihood, as measured by MEG.