Clinical Trial

Improvement of Quality of Life by Cannabinoids in Oncologic Patients

Study acronym: BELCANTO
Recruiting Phase 2
View on ClinicalTrials.gov →
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 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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-10-18; most recent amendment 2024-10-23.
Status change: Not Yet Recruiting → Recruiting 2024-09-16
Trial Details
NCT Number NCT06097533
Lead Sponsor University Hospital Schleswig-Holstein
Collaborators: Avextra Pharma GmbH, SocraMetrics GmbH
Conditions Medical Oncology, Palliative Care, Quality of Life, Cannabinoids
Enrollment 170 participants
Start Date 2024-04-08
Primary Completion 2026-11-30 (estimated)
Study Completion 2026-11-30 (estimated)
Updated on ClinicalTrials.gov 2024-10-26