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

BELCANTO

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.

2023-12-01

2026-11-30

2026-11-30

Not yet recruiting

Early phase I

170

Inclusion Criteria: * ≥25 years old and legally competent * Palliative oncological therapy * ECOG status 1, 2 or 3, incapacitated for work * ESAS TSDS \> 15 * Nutritional Risk Screening \> 3 * Pain numerical rating scale \> 3 * informed consent * for WOCBP: * Negative pregnancy test * Reliable contraception (Pearl Index \< 1%) Exclusion Criteria: * nausea/vomiting * Inability to understand and complete the questionnaires * Cannabis use in the last 2 years * Alcohol addiction * Pregnancy/lactation * Contraindications or intolerance to the study medication * Simultaneous participation in other clinical studies * Any other condition as judged by the investigator, e.g. non-compliance

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multi-center, prospective, interventional, randomized, two-arm, placebo-controlled, parallel, double-blinded clinical trial according to German Drug Law (AMG)/GCP and German Narcotic Drugs Act (BtMG)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'IMPs are centrally blinded and randomised at the pharmacy.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 170, 'type': 'ESTIMATED'}}

2023-10-24