Effect of a reduced dose on cognitive side effects of enzalutamide in frail (m)CRPC patients

Phase 4

Completed

Conditions: prostaatkanker
10038597

Registration Number: NL-OMON52805

Lead Sponsor: Afdeling Apotheek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

- Frail* male patients with prostate cancer who will start treatment with
enzalutamide
(* Frail is defined as a score on the comprehensive G8 assessment with cut-off
<12 points
and score >grade 1 for Central Nervous Disorders according to the Common
Toxicity Criteria Adverse Event (CTCAE) criteria, of one of the following:
Fatigue, Concentration impairment, cognitive disturbance, amnesia, depressed
level of consciousness, memory impairment, hypersomnia.)
- Age at least 18 years
- Patient who are able and willing to give written informed consent prior to
screening and enrolment
- Patients from whom it is possible to collect blood samples
- Patients who are willing to answer the questionnaires
- Life expectancy of > 6 months
- Capable of understanding and answering Dutch tests and questionnaires, as
determined by the investigator

Exclusion Criteria

- Other causes for cognition change (change in dose of
opioids/sedatives/benzodiazepines) during last 2 weeks before study)
- Use of psychostimulantia such as methylphenidate within 1 week of start of
study
- Diagnosed with medical conditions that affect cognition: Dementia, Alzheimer
disease, Parkinson*s disease, psychiatric disorders that affect cognition other
than depression or anxiety complaints related to the disease
- Active infection or other comorbidities that may contribute to fatigue or
cognition change within 4 weeks of study entry
- Clinical relevant anaemia

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- The primary aim is to show that a reduced dose (120mg OD) results in less<br /><br>fatigue (measured by the change in FACIT-fatigue subscale score) after 6 weeks<br /><br>of therapy compared to the standard dose (160mg OD) for frail metastatic<br /><br>castration resistant prostate cancer patients.</p><br>

Secondary Outcome Measures