No registrations found.
ID
Source
Brief title
Health condition
fatigue, depression, cognition in low-grade glioma patients
Sponsors and support
VU University Medical Center
P.O. Box 7057
1007 MB Amsterdam
Intervention
Outcome measures
Primary outcome
The main study parameters are scores on the CIS, MOS, SF-36, BCM and neuropsychological assessment on the three assessment moments.
Secondary outcome
Secondary study parameter is synchronization likelihood, as measured by MEG.
Background summary
N/A
Study objective
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.
Study design
1. Baseline, before treatment;
2. After first 6 weeks of treatment;
3. After second 6 weeks of treatment.
Intervention
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.
VU University Medical Center
M. Klein
Van der Boechorststraat 7
Amsterdam 1081 BT
The Netherlands
+31 20 4448432
m.klein@vumc.nl
VU University Medical Center
M. Klein
Van der Boechorststraat 7
Amsterdam 1081 BT
The Netherlands
+31 20 4448432
m.klein@vumc.nl
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;
3. Written informed consent.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1623 |
| NTR-old | NTR1721 |
| Other | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |