Trial intelligence / Profile preview

BELCANTO: Cannabinoids for Quality of Life in Oncologic Patients

NCT06097533Phase 2

Key facts

Status: Terminated
Start: Apr 2024
Primary completion: Feb 2026
Countries: 1
Sponsor: Universitätsklinikum Schleswig-Holstein
Modality: Small Molecules

Drugs: Avextra 10/10
Conditions: cancer

Overview

Phase 2, randomised trial in cancer comparing Cannabisextrakt Avextra 10/10 Lösung with Placebo (2 arms). Primary endpoint: Edmonton Symptom Assessment System total symptom distress score at 12 days. Started Apr 2024; status: terminated.

Design

2 arms

Study design: Randomized

Cannabisextrakt Avextra 10/10 Lösung
Solution with tetrahydrocannabinol and cannabidiol
Placebo
Sesame oil, Ph.Eur. Linseed oil, Ph.Eur

Who it enrols

Patients >= 25 years old receiving palliative oncological therapy with ECOG 1-3, ESAS TSDS >= 16, Nutritional Risk Screening >= 3, and Pain NRS >= 4. Excludes patients with recent severe nausea/vomiting, cannabis use in the last 6 weeks, alcohol addiction, or psychosis.

Endpoints

Primary

Edmonton Symptom Assessment System total symptom distress score12 days

Secondary

Global Patient's Assessment8 weeks
Opioid dose as morphine equivalent8 weeks
Defined daily dosages of neuropharmaceuticals8 weeks
Edmonton Symptom Assessment System total symptom distress score8 weeks
Inappetence8 weeks
NCCN distress thermometer8 weeks
Pain as Visual Analog Scale8 weeks
Pittsburgh Sleep Quality Index8 weeks

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