Status:
RECRUITING
Improvement of Quality of Life by Cannabinoids in Oncologic Patients
Lead Sponsor:
University Hospital Schleswig-Holstein
Collaborating Sponsors:
Avextra Pharma GmbH
SocraMetrics GmbH
Conditions:
Medical Oncology
Palliative Care
Eligibility:
All Genders
25+ years
Phase:
PHASE2
Brief Summary
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 car...
Detailed Description
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 week...
Eligibility Criteria
Inclusion
- ≥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%)
Exclusion
- 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
Key Trial Info
Start Date :
April 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06097533
Start Date
April 8 2024
End Date
November 30 2026
Last Update
October 26 2024
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH)
Hamburg, Hamburg, Germany, 20246
2
University Hospital Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105
3
University Hospital Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105
4
University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany