Primary:o To compare effort- and/or reward-related neural activity between cancer survivors and healthy controlso To assess whether cancer-related fatigue is related to effort- and/or reward-related neural activitySecondary objectives:o To assess…
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
kanker-gerelateerde vermoeidheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Task-related activity during effort-based decision making
- Self-reported fatigue
Secondary outcome
- Individual levels of high-sensitive C-reactive protein (CRP) on testing day
- Resting-state functional connectivity patterns
Background summary
Post-cancer fatigue is one of the most prevalent and debilitating side -effects
of cancer and its treatment. Fatigue symptoms are part of the sickness
syndrome, a set of behavioral symptoms including fatigue, depressive symptoms
and reduced engagement in activities that are triggered by treatment-induced
inflammation.
These symptoms are considered adaptive during chemotherapeutic treatment, but
they can become maladaptive if they persist long after curative treatment.
Currently, little is known on what (neural) mechanisms may underlie the
persistence of cancer-related fatigue.
Fatigue is intrinsically linked to reduced motivation and alterations in
effort-reward decision making. Neuroscience research has shown that effort and
reward weighting are two dissociable constructs that are processed by different
neuronal brain networks. Several studies suggest that repeated exposure to
inflammation (as happens during multiple cycles of chemotherapeutic treatments)
can produce long lasting changes in brain function and neurochemistry, which
may ultimately result in long-lasting alterations in motivational behaviours
and mood. The current study will therefore use task-related fMRI during an
effort-based decision-making task to elucidate the neural mechanisms of
cancer-related fatigue.
To this end, we will measure fatigue-related motivational and neural changes in
young males treated for testicular cancer 2-10 years after treatment. Fatigue
will be measured as a two-dimensional behavioural construct involving effort
and reward weighting in choices on whether or not to engage in physical
activities for reward. Participants will make these choices whilst laying in an
MRI-scanner. This allows us to investigate the separate neural networks for
effort and reward, as well as the integration of the two. The results of this
study will provide insights into behaviors and their possible neural mechanisms
that contribute to persistent cancer-related fatigue.
Study objective
Primary:
o To compare effort- and/or reward-related neural activity between cancer
survivors and healthy controls
o To assess whether cancer-related fatigue is related to effort- and/or
reward-related neural activity
Secondary objectives:
o To assess whether effort- and/or reward-related neural activity is associated
with low-grade peripheral inflammation (CRP)
o To explore resting-state functional connectivity patterns related to
cancer-related fatigue and peripheral inflammation
Study design
A cross-sectional, observational design in 50 cancer survivors and 45 healthy
controls
Study burden and risks
The burden consists of a phone call followed by a testing day at the Donders
Institute of 2 hours. During the testing day, participants will perform one
behavioural task, which will partly be done in the MRI-scanner and partly on
the regular PC, and undergo a resting state scan. In addition, they will have a
finger prick to determine high-sensitive CRP and perform a short working memory
task. Lastly, they will fill out some online questionnaires at home (30-40
minutes).
Kapittelweg 29
Nijmegen 6525EN
NL
Kapittelweg 29
Nijmegen 6525EN
NL
Listed location countries
Age
Inclusion criteria
For all participants: • Written informed consent • Male • Age between 18 and 50
yrs • Sufficient command of the Dutch language (to answer questionnaires)
For patients: • Unilateral orchiectomy • 3 or 4 cycles of BEP or EP treatment
regimen
Exclusion criteria
For all participants: • Presence of acute infection or inflammation on day of
testing (body temperature >38) • Current use of prescribed psychotropic, pain
or anti-inflammatory drugs • (history of) long-term (> 6 months) daily use of
over-the-counter NSAIDs (ibuproven, diclofenac, naproxen) (for patients:
besides those used during cancer-treatment) • Current use of over-the-counter
corticosteroids, anti-histamic or anti-inflammatory drugs (participants that
use corticosteroid moistures or hay-fever drugs are asked to not use it on the
testing day) • Obesity (BMI>30) • (history of) metabolic disease (e.g.
diabetes) • (history of) cardiovascular events • (history of) neurological or
psychiatric symptoms/disease • (history of) chronic inflammatory disease (e.g.
rheumatoid arthritis, Crohns disease) • (history of) hypo/hyperthyroide •
(history of) chronic pain (>6 months) (for patients before diagnosis) •
(history of) chronic fatigue syndrome or fibromyalgia (for patients before
diagnosis) • (history of) hypogonadism/ hormonal disturbance or supletion (for
patients before diagnosis) • Metal objects in or around the body •
Claustrophobia • Glaucoma or increased risk for glaucoma • No presence of
metastatic disease or relapse • No patients who received radiotherapy because
other treatment with different side effects
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 |
|---|---|
| CCMO | NL76541.091.21 |