Improvement of Quality of Life by Cannabinoids in Oncologic Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age25+
SponsorUniversity Hospital Schleswig-Holstein
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥25 years old and legally competent
Palliative oncological therapy
ECOG status 1, 2 or 3, incapacitated for work
ESAS TSDS > or equals 16
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cannabisextrakt Avextra 10/10 Lösung
Drugmedical cannabinoids
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Cannabisextrakt Avextra 10/10 LösungExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 daysSecondary outcomes
1
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 weeks2
opioid dose as morphine equivalent
Time frame
12 days, 4 weeks, 8 weeks3
defined daily dosages (DDD) of neuropharmaceuticals
Time frame
12 days, 4 weeks, 8 weeks4
ESAS-TSDS score
Edmonton Symptom Assessment System
Time frame
4 weeks, 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Schleswig-Holstein
Lead sponsor
Avextra Pharma GmbH
Collaborator
SocraMetrics GmbH
Collaborator
Source ClinicalTrials.gov