Actively Recruiting
Improvement of Quality of Life by Cannabinoids in Oncologic Patients
Led by University Hospital Schleswig-Holstein · Updated on 2024-10-26
170
Participants Needed
4
Research Sites
138 weeks
Total Duration
On this page
Sponsors
U
University Hospital Schleswig-Holstein
Lead Sponsor
A
Avextra Pharma GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Improvement of Quality of Life by Cannabinoids in Oncologic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
≥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 will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH)
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
Actively Recruiting
2
University Hospital Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105
Actively Recruiting
3
University Hospital Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105
Actively Recruiting
4
University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Actively Recruiting
Research Team
J
Justus Domschikowski, M.D.
CONTACT
T
Thomas Herdegen, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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