A Phase 2 interventional study of Cannabisextrakt Avextra 10/10 Lösung in Medical Oncology, Palliative Care and Quality of Life, sponsored by University Hospital Schleswig-Holstein. Terminated at 3 sites in Germany. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by University Hospital Schleswig-Holstein · Phase 2, Interventional, and Treatment
Given the current recruitment rate and the changes in the treatment landscape, there is no reasonable expectation of achieving the planned sample size.
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.
170 oncological patients in palliative treatment will be randomized 1:1 to an THC:CBD-interventional arm and an placebo-arm. At the timepoints baseline, 12±2 days, 18±3 days, four weeks and eight weeks, the global burden of symptoms (ESAS TSDS), quality of life (EORTC QLQ C15 PAL) and other parameter will be measured and the intraindividual difference in comparison with the baseline will be compared between the groups. This study is intended to provide a significant contribution to Evidence-based medicine (EbM) of CAM in palliative medicine as well as for elderly and severely ill subjects (resp.) in general.
The following gain of knowledge is expected:
University Hospital Schleswig-Holstein is the lead sponsor of 163 studies on the registry; 25 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
for WOCBP:
Exclusion Criteria:
Solution with tetrahydrocannabinol and cannabidiol
Drug: Cannabisextrakt Avextra 10/10 Lösung
Sesame oil, Ph.Eur. Linseed oil, Ph.Eur
Drug: Cannabisextrakt Avextra 10/10 Lösung
medical cannabinoids
Also known as: Cannabisextrakt Avextra 10/10 solution
ESAS-TSDS score
Symptom change as percentage change in ESAS-TSDS score after 12±2 days compared to baseline between intervention group and placebo control group.
Time frame: 12 days
Global Patient's Assessment
Scale to evaluate the absolute severity and the change in comparison with the preceding measurement
Time frame: 12 days, 4 weeks, 8 weeks
opioid dose as morphine equivalent
Time frame: 12 days, 4 weeks, 8 weeks
defined daily dosages (DDD) of neuropharmaceuticals
Time frame: 12 days, 4 weeks, 8 weeks
ESAS-TSDS score
Edmonton Symptom Assessment System
Time frame: 4 weeks, 8 weeks
inappetence
Time frame: 12 days, 4 weeks, 8 weeks
NCCN distress thermometer
Time frame: 12 days, 4 weeks, 8 weeks
pain as VAS
Time frame: 12 days, 4 weeks, 8 weeks
sleep quality (Pittsburgh Sleep Quality Index, PSQI)
contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available)
Time frame: 12 days, 4 weeks, 8 weeks
EORTC QLQ-C15 PAL
European Organization for Research and Treatment of Cancer Quality of Life Palliative
Time frame: 12 days, 4 weeks, 8 weeks
Adverse events (AE)
Adverse events (AE) incidence, frequency and severity coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and scored according to the NCI Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: up to 8 weeks
C-reactive protein (CRP)
Time frame: 12 days, 4 weeks, 8 weeks
all endpoints stratified by stage of oncological disease (ICD-10), treatment modalities, gender, weight, high/low dose, renal function and age whereever possible and meaningful
Time frame: 12 days, 4 weeks, 8 weeks
Plan to share: Undecided — Aggregated data can be shared. Individual data only after internal and IRB review.
No publications or documents are linked to this record.
Given the current recruitment rate and the changes in the treatment landscape, there is no reasonable expectation of achieving the planned sample size.
Given the current recruitment rate and the changes in the treatment landscape, there is no reasonable expectation of achieving the planned sample size.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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