Improvement of Quality of Life by Cannabinoids in Oncologic Patients
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Medical Oncology, Palliative Care, Quality of Life, Cannabinoids
In brief
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.
Key facts
- Study ID
- NCT06097533
- Run by
- University Hospital Schleswig-Holstein
- People needed
- 170
- Starts
- 2024-04-08
- Expected to finish
- 2026-11-30
- Last updated by the study team
- 2024-10-26
Who can join
Age: 25 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥25 years old and legally competent
- Palliative oncological therapy
- ECOG status 1, 2 or 3, incapacitated for work
- ESAS TSDS > or equals 16
- Nutritional Risk Screening > or equals 3
- Pain numerical rating scale > or equals 4
- informed consent
- for WOCBP:
- Negative pregnancy test
- Reliable contraception (Pearl Index < 1%)
You may not qualify if…
- 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
- Pregnancy/lactation
- Contraindications or intolerance to the study medication (esp. psychosis)
- Simultaneous participation in other clinical studies (sumulataneous participation in non-interventional studies (i.e. biomarker-studies, registries) is allowed, if the study-aim does not interfere with measures of the second study)
- Any other condition as judged by the investigator, e.g. non-compliance
Where it is running
- Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH) — Hamburg, Free and Hanseatic City of Hamburg, Germany (enrolling)
- University Hospital Schleswig-Holstein — Kiel, Schleswig-Holstein, Germany (enrolling)
- University Hospital Schleswig-Holstein — Kiel, Schleswig-Holstein, Germany (enrolling)
- University Hospital Schleswig-Holstein — Lübeck, Schleswig-Holstein, Germany (enrolling)
Full record on ClinicalTrials.gov
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