Identifying motivational alterations associated with cancer-related fatigue: a longitudinal study in testicular cancer patients

Recruiting

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

• Registration Number: NL-OMON49467
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 105

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
• BEP or EP treatment regimen (for sugery+chemo group)
• No patients who received radiotherapy because of non-comparable tumor-types
and treatment side-effects

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 suppletion (for patients
before diagnosis)
• (history of) renal failure

For all patients
• Patients who received radiotherapy because of non-comparable tumor-types and
treatment side-effects

For all healthy participants
• Severe fatigue (CIS-fatigue <35)

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>• 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>TNFa, IL-1 and IL-6)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Cortisol Awakening Response (CAR)<br /><br>• Potential health-related, stress-related, and psychosocial predictors (All<br /><br>questionnaires 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)<br /><br>- reward and punishment based learning</p><br>