Improvement of Quality of Life by Cannabinoids in Oncologic Patients (BEfindLichkeitsverbesserung Unter CANnabinoid-ExtrakTen Bei Onkologischen Patienten)

What this Trial Is About

Researchers are evaluating whether the cannabis extract Avextra 10/10 solution can help improve symptoms and well-being in patients receiving palliative care for cancer. The study aims to show if this treatment can reduce the overall symptom burden better than a placebo over about 12 days, using the Edmonton Symptom Assessment System total symptom distress score as the main measurement. This Phase 2 randomized trial focuses on adults with advanced cancer and includes careful monitoring of quality of life and other health parameters. In this study, 170 palliative oncology patients are randomly assigned to receive either the cannabinoid solution containing tetrahydrocannabinol (THC) and cannabidiol (CBD) or a placebo made of sesame and linseed oils. The treatment periods include assessments at baseline, after 12 days, around 18 days, and follow-ups at four and eight weeks. These timepoints help compare symptoms, quality of life, and other factors between the two groups to better understand the potential effects of the cannabis extract. Participants will be involved in several assessments, including symptom burden, quality of life questionnaires, pain ratings, sleep quality, and distress levels at multiple visits during the first eight weeks. Researchers will also track medication use, inflammatory markers, and any side effects. The study includes safety monitoring and evaluates outcomes at regular intervals, aiming to provide evidence about complementary medicine use in seriously ill cancer patients over the course of their palliative care.

Improvement of Quality of Life by Cannabinoids in Oncologic Patients