search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Reducing fatigue, depression, and cognitive deficits with modafinil in low-grade glioma patients.


- candidate number5443
- NTR NumberNTR1721
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-mrt-2009
- Secondary IDs 
- Public TitleReducing fatigue, depression, and cognitive deficits with modafinil in low-grade glioma patients.
- Scientific TitleThe effect of modafinil on fatigue, cognition and functional connectivity in low-grade glioma patients: a double-blind randomized trial.
- ACRONYMN/A
- hypothesis1. Modafinil influences fatigue, cognitive functioning, and quality of life of LGG patients;
2. There is a correlation between (changes in) fatigue, cognition, and quality of life on the one hand, and functional connectivity in the brains of LGG patients on the other.
- Healt Condition(s) or Problem(s) studiedDepression, Glioma, Fatigue
- Inclusion criteria1. 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;
3. Written informed consent.
- Exclusion criteria1. History of chemotherapy treatment;
2. Anti-tumor treatment other than antiepileptic drugs (e.g. chemotherapy, radiotherapy, corticosteroids);
3. Psychiatric disease or symptoms;
4. Insufficient mastery of the Dutch language;
5. Inability to communicate adequately.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2009
- planned closingdate1-okt-2010
- Target number of participants64
- InterventionsPatients will be randomized into two groups. These groups will first receive six weeks of treatment (with either placebo or modafinil), followed by a wash-out period of one week. Hereafter, another treatment period of six weeks will take place, in which patient groups will receive placebo or modafinil respectively (opposite of first treatment). Treatment will begin with 100 mg modafinil, or matching placebo, upon waking and at lunch (200 mg/day). After one week, the dose will be doubled (400 mg/day). If patients experience adverse events at the higher dose, they will be allowed to decrease the medication to the previous dose. Patients will continue at either 200 mg/day or 400 mg/day until the second visit, six weeks after the initial visit.
- Primary outcomeThe main study parameters are scores on the CIS, MOS, SF-36, BCM and neuropsychological assessment on the three assessment moments.
- Secondary outcomeSecondary study parameter is synchronization likelihood, as measured by MEG.
- Timepoints1. Baseline, before treatment;
2. After first 6 weeks of treatment;
3. After second 6 weeks of treatment.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. M. Klein
- CONTACT for SCIENTIFIC QUERIESDr. M. Klein
- Sponsor/Initiator VU University Medical Center, Department of Neurology
- Funding
(Source(s) of Monetary or Material Support)
Nuts/Ohra
- PublicationsBoele, 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.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD11-mrt-2009 - 18-apr-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl