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

Qualifiers

≥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

Treatments tested in this trial

  • Cannabisextrakt Avextra 10/10 Lösung

Treatment groups

170 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital Schleswig-Holstein

Lead sponsor

Avextra Pharma GmbH

Collaborator

SocraMetrics GmbH

Collaborator