Cannabisextrakt Avextra 10/10 Lösung
medical cannabinoids
Cannabisextrakt Avextra 10/10 solution
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-10-16
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
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: * substancial and reliable effects of CAM in elderly subjects being in a multimorbid and psychologically very stressful situation of illness and life (resp.). * substancial and reliable effects of CAM in aduld subjects being in a oncologically and palliative situation of illness and life (resp.). * compatibility of a CAM-therapy in multimorbid patients with polypharmacotherapy. * importance of CAM for the very frequent psychovegetative disturbance and comorbidities of many illnesses like sleepnesness, loss of appetite, nausea, fear and affective disturbance. * possible reduction of costs and improved economics through CAM
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
medical cannabinoids
Cannabisextrakt Avextra 10/10 solutionEligibility
primary outcomes
Time frame: 12 days
Symptom change as percentage change in ESAS-TSDS score after 12±2 days compared to baseline between intervention group and placebo control group.
secondary outcomes
Time frame: 12 days, 4 weeks, 8 weeks
Scale to evaluate the absolute severity and the change in comparison with the preceding measurement
Time frame: 12 days, 4 weeks, 8 weeks
Time frame: 12 days, 4 weeks, 8 weeks
Time frame: 4 weeks, 8 weeks
Edmonton Symptom Assessment System
Time frame: 12 days, 4 weeks, 8 weeks
Time frame: 12 days, 4 weeks, 8 weeks
Time frame: 12 days, 4 weeks, 8 weeks
Time frame: 12 days, 4 weeks, 8 weeks
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
European Organization for Research and Treatment of Cancer Quality of Life Palliative
Time frame: up to 8 weeks
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: 12 days, 4 weeks, 8 weeks
Time frame: 12 days, 4 weeks, 8 weeks
Publications
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Organisations & named parties
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