(1) investigating the influence of modafinil on fatigue, cognitive functioning, and quality of life of LGG patients, (2) assessing the correlation between (changes in) fatigue, cognition, and quality of life on the one hand, and functional…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The CIS will be used as main study parameter, as a measure of fatigue. Quality
of Life will be assessed by means of the SF-36, BCM20, and MOS. The CES-D will
be administered to investigate levels of depression. A neuropsychological test
battery assessing a range of cognitive functions will be administered. MEG
recordings will take place during resting state, which means no-task and
eyes-closed; analyses will be done with synchronization likelihood. Assessment
of all parameters will take place at baseline (pretreatment; t0), t1
(immediately after six weeks of first treatment with placebo or modafinil) and
t2 (immediately after six weeks of second treatment with placebo or modafinil).
Secondary outcome
n.a.
Background summary
Modafinil has been shown to reduce fatigue and possibly cognitive deficits and
mood in diverse patient groups, hereby increasing patients* quality of life.
Most low-grade glioma patients suffer from fatigue. However, the effects of
modafinil have never been investigated in a homogeneous group of low-grade
glioma (LGG) patients. We have previously shown that cognitive functioning is
correlated with synchronization of brain activity between different areas, a
concept known as functional connectivity. Also, cognitive dysfunction in glioma
patients was shown to correlate with functional connectivity patterns. It
remains to be determined whether fatigue also has a neurophysiological
correlate in the brain, and whether a modafinil-induced reduction in fatigue
and cognitive disturbances is reflected by changes in functional connectivity
patterns. Understanding the neurophysiological correlates of fatigue will
facilitate the development of rational treatment of this symptom in glioma
patients.
Study objective
(1) investigating the influence of modafinil on fatigue, cognitive functioning,
and quality of life of LGG patients, (2) assessing the correlation between
(changes in) fatigue, cognition, and quality of life on the one hand, and
functional connectivity in the brain on the other.
Study design
Double-blind placebo-controlled intervention study.
Intervention
Patients will randomly be divided 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
(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 treatment at either 200 mg/day or 400 mg/day until
the third visit, six weeks after start of the treatment.
Study burden and risks
The burden of participation for patients consists of (1) a number of visits to
the outpatients* clinic (at the three research moments), (2) administration of
a neuropsychological test battery at the three research moments, (3)
examination through magnetoencephalography (MEG) at the three research moments,
and (4) use of modafinil and placebo for twelve weeks in total. The
neuropsychological assessment and MEG measurements are non invasive and do not
involve any risk. Minimal side effects of modafinil use have been reported.
However, we believe that the possible decrease of fatigue symptoms and thereby
enhancement in quality of life of patients is of great importance for their
well-being, and feel that the burden and risk of participation are
proportionate to the expected gains of this study.
Van der Boechorststraat 7
1081 BT Amsterdam
NL
Van der Boechorststraat 7
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
(1) Reported severe fatigue (score > 35) on the Checklist Individual Strength (CIS), (2) histologically proven LGG without signs of tumor recurrence in the last year, and (3) written informed consent.
Exclusion criteria
(1) anti-tumor treatment other than antiepileptic drugs (e.g. chemotherapy, radiotherapy, corticosteroids), (2) psychiatric disease or symptoms, (3) insufficient mastery of the English or Dutch language, (4) inability to communicate adequately.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2007-003102-10-NL |
| CCMO | NL18598.029.08 |