brain tumor glioma or other primary brain tumor
Conditions
Interventions
All patients will receive both 600 mg CBD and a placebo.
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - diagnosis of primary brain tumor; - >=18 years of age; - moderate to severe anxiety, defined as S-STAI score >= 44 at moment of screening; - ability to understand and sign informed consent in Dutch; - stable disease, i.e. no oncological treatment for
Exclusion criteria
Exclusion criteria: - corticosteroid use, unless in a stable dose >= 8 weeks; - regular cannabis use currently or in past history (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study outcome is anxiety, as measured with the state-subscale of the state-trait anxiety inventory (S-STAI). Anxiety and distress will also be measured using the hospital anxiety and depression scale (HADS) and the beck anxiety inventory(BAI). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary study outcomes are: - Depressive complaints as measured with the Beck Depression Inventory (BDI) - Sleep, measured with the Pittsburgh Sleep Quality Index (PSQI) - Quality of life as measured with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) and the Brain tumor-specific HRQOL (EORTC QLQ-BN20) - Fatigue, measured with the CIS20r subscale | — |
Countries
Netherlands
Outcome results
None listed