About this trial
The goal is to explore whether the application of cannabis extract Avextra 10/10 solution is suitable to contribute to an improvement in the symptom burden and well-being of oncological palliative care patients. The primary objective of the study is to demonstrate the improvement in global symptom burden in the intervention arm compared to the placebo control group over a period of 12±2 days, as measured by a percentage change in the value of the Edmonton Symptom Assessment System total symptom distress score (ESAS TSDS) at baseline and after 12±2 days.
Eligibility criteria
Qualifiers
≥25 years old and legally competent
Palliative oncological therapy
ECOG status 1, 2 or 3, incapacitated for work
ESAS TSDS > or equals 16
Disqualifiers
nausea > or equals grade 3 (CTCAE) or vomiting > or equals grade 2 (CTCAE) in the preceding week
Inability to understand and complete the questionnaires
Cannabis use in the last 6 weeks
Alcohol addiction
Trial design
Treatments tested in this trial
- Cannabisextrakt Avextra 10/10 Lösung
Treatment groups
Sponsors and collaborators
University Hospital Schleswig-Holstein
Lead sponsor
Avextra Pharma GmbH
Collaborator
SocraMetrics GmbH
Collaborator