To investigate the effect of a three-week treatment with cannabidiol (CBD) on anxiety in patients with a primary brain tumor that have no active oncological treatment. Depression, fatigue and general quality of life are secondary outcome measures.…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Gliomas are primary malignant brain tumors that are incurable to date and lead
to a severely reduced quality of life. For these tumors only palliative
oncological treatment exist. Due to the short life expectancy, improving
quality of life is essential in these patients. Many glioma patients currently
use non-medicinal cannabinoids for presumed symptom relieve. Cannabidiol (CBD)
is freely available in the Netherlands, which presumably leads to this
cannabinoid being the most frequently used. Studies are lacking that
investigated the effect of cannabinoids on well-being in this population.
Consequently, a knowledge gap exists. At present health care providers cannot
advice their neuro-oncological patients on the use of cannabinoids nor can they
prescribe this medication. The main symptoms during the stable phase disease
are fatigue, depressed mood and anxiety.
Study objective
To investigate the effect of a three-week treatment with cannabidiol (CBD) on
anxiety in patients with a primary brain tumor that have no active oncological
treatment. Depression, fatigue and general quality of life are secondary
outcome measures. This study is part of the GRIP-project, a platform trial to
investigate interventions aimed at improving quality of life in patients with
brain tumors in five intervention arms.
Study design
A double-blind, placebo-controlled crossover study. Patients will be randomized
to 600 mg CBD or placebo as first treatment. CBD or placebo will be
administered during three weeks followed by a washout period of two weeks
before the second treatment period starts.
Intervention
All patients will receive both 600 mg CBD and a placebo.
Study burden and risks
The risks for patients participating in this study compromise toxicity from
CBD. Most frequently reported adverse effects are drowsiness and fatigue. Liver
functions will be monitored as they can increase after CBD use. The
questionnaires can be time-consuming and be a burden to patients to some
extent. On the other hand, patients will possibly experience a decrease in
anxiety, depressive symptoms and an increase in sleep quality and general
quality of life. As cannabinoids are currently extensively used by glioma
patients, we consider the benefit of filling the existing knowledge gap to
outweigh the burden of potential side effects.
Boelelaan 1117
Amsterdam 1081HV
NL
Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
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 <=2 months prior to
inclusion;
- no radiological progression on the most recent MRI, not older than 6 months,
and no clinical progression within the most recent two months.
Exclusion criteria
- corticosteroid use, unless in a stable dose >= 8 weeks;
- regular cannabis use currently or in past history (<=2 weeks);
- substance abuse (defined as use of hard drugs, or alcohol use more than 3
units per day);
- history of psychosis or anxiety disorder;
- alterations in SSRI/SNRI use or dosage during the prior two months;
- psychological or psychiatric treatment during the prior two months aimed at
anxiety;
- current pregnancy or have given birth less than three months ago;
- currently breastfeeding;
- KPS <=70;
- uncontrolled hyperthyroidism;
- severe liver disorders (AST, ALT and/or gamma-GT more than three times the
upper limit);
- severe kidney disorders (eGFR<=30).
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| Other | NL9623 |
| EudraCT | EUCTR2020-004294-48-NL |
| CCMO | NL76031.029.21 |