1. 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…
ID
Bron
Verkorte titel
Aandoening
fatigue, depression, cognition in low-grade glioma patients
Ondersteuning
VU University Medical Center
P.O. Box 7057
1007 MB Amsterdam
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main study parameters are scores on the CIS, MOS, SF-36, BCM and neuropsychological assessment on the three assessment moments.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
1. 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.
Onderzoeksopzet
1. Baseline, before treatment;
2. After first 6 weeks of treatment;
3. After second 6 weeks of treatment.
Onderzoeksproduct en/of interventie
Patients 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.
Publiek
VU University Medical Center
M. Klein
Van der Boechorststraat 7
Amsterdam 1081 BT
The Netherlands
+31 20 4448432
m.klein@vumc.nl
Wetenschappelijk
VU University Medical Center
M. Klein
Van der Boechorststraat 7
Amsterdam 1081 BT
The Netherlands
+31 20 4448432
m.klein@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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;
3. Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
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