Investigate whether a low-dose of hydrocortisone (cortisol) reduces neuropsychiatric symptoms in glioma, meningioma and brain metastasis patients who are perioperatively treated with a high dose of the synthetic glucocorticoid dexamethasone,…
ID
Source
Brief title
Condition
- Other condition
- Deliria (incl confusion)
Synonym
Health condition
Depressie, Manie, Angst, Cognitie, Slaap
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameter is neuropsychiatric adverse effects measured by the Brief
Psychiatric Rating Scale (BPRS).
Secondary outcome
Secondary parameters are neuropsychiatric adverse effects measured with
different questionnaires (Hospital Anxiety and Depression Scale, Altman
Self-Rating Mania scale, Positive Affect Negative Affect Scale, Delirium
Observation Scale); neurophysiological functioning assessed with different
cognitive tests, sleep quality measured with the Leeds Sleep Evaluation
Questionnaire (LSEQ) and quality of life with QLQ-C30+BN20.
Background summary
Over 800.000 individuals are treated annually in The Netherlands with synthetic
glucocorticoids like dexamethasone. These drugs are life-saving but induce
significant neuropsychiatric complaints in thousands of patients. Dexamethasone
acts only via glucocorticoid receptors (GRs), while the endogenous hormone
hydrocortisone stimulates in brain also mineralocorticoid receptors (MRs). An
unwanted side effect of dexamethasone is the strong suppression of
hydrocortisone levels. This depletes brain MRs from ligand, which is known to
compromise brain function. We hypothesize that co-treatment with a
physiological dose of hydrocortisone will re-fill brain MRs and prevent - or
reduce - psychopathology caused by synthetic glucocorticoids.
Study objective
Investigate whether a low-dose of hydrocortisone (cortisol) reduces
neuropsychiatric symptoms in glioma, meningioma and brain metastasis patients
who are perioperatively treated with a high dose of the synthetic
glucocorticoid dexamethasone, compared to patients treated with high dose
dexamethasone alone.
Study design
A randomized double-blind placebo-controlled trial.
Intervention
Patients will be randomized to hydrocortisone versus placebo, as add-on to the
regular dexamethasone scheme peri-operative. Hydrocortisone/placebo will be
administered orally: 2x 10 mg/day.
Study burden and risks
There are no additional risks for the study intervention. When hydrocortisone
is used as substitution therapy when the own cortisol production is too low,
the chance to get side effects are very small. Dexamethason causes suppression
of the bodies own cortisol production. The hydrocortisone administered to the
dexamethasone will restore the normal physiological cortisol levels in the
body. The administered hydrocortisone should prevent the negative side effects
of dexamethasone. This intervention has been performed in 1 other study of
Warris et al. (2016). They tested the same principle but in pediatric patients
with leukemia. They found that in children who suffered from most severe side
effects, the hydrocortisone was able to reduce this. The burden for the
subjects in this study is estimated to be 5 hours spread over 3 months.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- Cranial glioma, meningioma or brain metastasis scheduled to undergo surgery
(resection)
- Minimal dose of peri-operative cumulative dexamethasone of 24mg or more in 6
days
- >=18 years
- Good clinical condition; KPS>=70
- Life expectancy >=6 months
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
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-003705-17-NL |
| CCMO | NL63350.058.18 |
| OMON | NL-OMON22627 |