Improvement of Quality of Life by Cannabinoids in Oncologic Patients

Quality of Life Clinical Trial

— BELCANTO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06097533
• Other study ID #: BELCANTO
• Secondary ID: 2022-004137-39DR
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: December 1, 2023
• Est. completion date: November 30, 2026

Study information

• Verified date: October 2023
• Source: University Hospital Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 170
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medical Oncology
• Palliative Care
• Quality of Life

Intervention

Drug:
• Cannabisextrakt Avextra 10/10 Lösung
medical cannabinoids

Locations

Country	Name	City	State
Germany	Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH)	Hamburg
Germany	University Hospital Schleswig-Holstein	Kiel	Schleswig-Holstein
Germany	University Hospital Schleswig-Holstein	Lübeck	Schleswig-Holstein

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein	Avextra Pharma GmbH, SocraMetrics GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ESAS-TSDS score	Symptom change as percentage change in ESAS-TSDS score after 12±2 days compared to baseline between intervention group and placebo control group.	12 days
Secondary	Global Patient's Assessment		12 days, 4 weeks, 8 weeks
Secondary	opioid dose as morphine equivalent		12 days, 4 weeks, 8 weeks
Secondary	defined daily dosages (DDD) of neuropharmaceuticals		12 days, 4 weeks, 8 weeks
Secondary	ESAS-TSDS score		4 weeks, 8 weeks
Secondary	inappetence		12 days, 4 weeks, 8 weeks
Secondary	NCCN distress thermometer		12 days, 4 weeks, 8 weeks
Secondary	pain as VAS		12 days, 4 weeks, 8 weeks
Secondary	sleep quality (Pittsburgh Sleep Quality Index, PSQI)		12 days, 4 weeks, 8 weeks
Secondary	EORTC QLQ-C15 PAL	European Organization for Research and Treatment of Cancer Quality of Life Palliative	12 days, 4 weeks, 8 weeks
Secondary	Adverse events (AE)	Adverse events (AE) incidence, frequency and severity coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and scored according to the NCI Common Terminology Criteria for Adverse Events (CTCAE)	up to 8 weeks
Secondary	C-reactive protein (CRP)		12 days, 4 weeks, 8 weeks
Secondary	all endpoints stratified by stage of oncological disease (ICD-10), treatment modalities, gender, weight, high/low dose, renal function and age whereever possible and meaningful		12 days, 4 weeks, 8 weeks