anxiety, depression, mania, delirium, sleep, cognition
Conditions
Interventions
Hydrocortisone or placebo as add-on to dexamethasone.
Sponsors
Leiden Univeristy Medical Center (LUMC)
Eligibility
Inclusion criteria
Inclusion criteria: - Cranial glioma or meningioma scheduled to undergo surgery (resection) - Minimal dose of peri-operative cumulative dexamethasone exposure of 24mg or more in 6 days - =18 years - Good clinical condition; KPS=70 - Life expectancy =6 months
Exclusion criteria
Exclusion criteria: - Non-native speakers of Dutch or insufficient command of the Dutch language - Patients that are unable to overview consequences of trial participation - Patients with severe aphasia - Patients that are not able to fill in the questionnaires because of cognitive impairments at the discretion of the physician - Patients with psychiatric diseases or neurological deficits that interfere with the study to the judgement of treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary parameter is neuropsychiatric adverse effects measured by the Brief Psychiatric Rating Scale (BPRS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters are neuropsychiatric adverse effects measured with different questionnaires (Hospital Anxiety and Depression Scale, Altman Self-Rating Mania scale and Positive Affect Negative Affect Scale); neurophysiological functioning assessed with different cognitive tests, sleep quality measured with actigraphy and the Leeds Sleep Evaluation Questionnaire (LSEQ) and quality of life with QLQ-C30+BN20. | — |
Contacts
Public ContactAnne-Sophie Koning
LUMC
Outcome results
None listed