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

The effect of modafinil on fatigue, cognition and functional connectivity in low-grade glioma patients: a double-blind randomized trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25601

Enrollment

Registered

2009-03-11

Start date

2009-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fatigue, depression, cognition in low-grade glioma patients

Interventions

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 tr

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
The main study parameters are scores on the CIS, MOS, SF-36, BCM and neuropsychological assessment on the three assessment moments.	—

Secondary

Measure	Time frame
Secondary study parameter is synchronization likelihood, as measured by MEG.	—

Contacts

Public ContactM. Klein

Department of Medical Psychology - D343 VU University Medical Center

m.klein@vumc.nl+31 20 4448432

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)