Identifying motivational alterations associated with cancer-related fatigue: a cross-sectional study in testicular cancer survivors

• Conditions: 10027946; kanker-gerelateerde vermoeidheid; cancer-related fatigue

• Registration Number: NL-OMON55202
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 92

Inclusion Criteria

For all participants (healthy and patients):
* Written informed consent
* Male
* Age between 18 and 50 yrs
* Sufficient command of the Dutch language (to answer questionnaires)

For all patients:
* Unilateral orchiectomy
* 3 or 4 cycles of BEP or EP treatment regimen

Exclusion Criteria

For all participants (healthy and patients):
* 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)

For all healthy participants
* No severe fatigue (CIS-fatigue <36)

For all survivors
* No presence of metastatic disease or relapse
* No patients who received radiotherapy because other treatment with different
side effects

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Individual weightings of effort and reward sensitivity, as measured with<br /><br>effort/reward weighting task<br /><br>* Fatigue score as determined by the Checklist Individual Strength (CIS)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Subjective mood ratings (including but not limited to fatigue, depressive<br /><br>mood, and anxiety) (All questionnaires are described below)<br /><br>* Plasma cytokine concentration profiles (including but not limited to CRP,<br /><br>TNF*, IL-1 and IL-6)<br /><br>* Cortisol Awakening Response (CAR)<br /><br>* Potential health-related, stress-related, and psychosocial predictors (All<br /><br>question-naires are described below)<br /><br>* General neurocognitive functioning (Amsterdam Cognition Scan (ACS) for<br /><br>replication of previous studies (Schagen et al 2008, Stouten-Kemperman et al<br /><br>2015b)</p><br>