BELCANTO: Improvement of Quality of Life by Cannabinoids in Oncologic Patients

Sponsor

University Hospital Schleswig-Holstein (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06097533

Collaborator

Avextra Pharma GmbH (Other), SocraMetrics GmbH (Industry)

170

Enrollment

Locations

Arms

Anticipated Duration (Months)

56.7

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Medical Oncology Palliative Care Quality of Life Cannabinoids	Drug: Cannabisextrakt Avextra 10/10 Lösung	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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)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)

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

IMPs are centrally blinded and randomised at the pharmacy.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2026

Anticipated Study Completion Date :

Nov 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cannabisextrakt Avextra 10/10 Lösung Solution with tetrahydrocannabinol and cannabidiol	Drug: Cannabisextrakt Avextra 10/10 Lösung medical cannabinoids
Placebo Comparator: Placebo Sesame oil, Ph.Eur. Linseed oil, Ph.Eur	Drug: Cannabisextrakt Avextra 10/10 Lösung medical cannabinoids

Arm

Intervention/Treatment

Experimental: Cannabisextrakt Avextra 10/10 Lösung

Solution with tetrahydrocannabinol and cannabidiol

Drug: Cannabisextrakt Avextra 10/10 Lösung

medical cannabinoids

Placebo Comparator: Placebo

Sesame oil, Ph.Eur. Linseed oil, Ph.Eur

Drug: Cannabisextrakt Avextra 10/10 Lösung

medical cannabinoids

Outcome Measures

Primary Outcome Measures

ESAS-TSDS score [12 days]
Symptom change as percentage change in ESAS-TSDS score after 12±2 days compared to baseline between intervention group and placebo control group.

Secondary Outcome Measures

Global Patient's Assessment [12 days, 4 weeks, 8 weeks]
opioid dose as morphine equivalent [12 days, 4 weeks, 8 weeks]
defined daily dosages (DDD) of neuropharmaceuticals [12 days, 4 weeks, 8 weeks]
ESAS-TSDS score [4 weeks, 8 weeks]
inappetence [12 days, 4 weeks, 8 weeks]
NCCN distress thermometer [12 days, 4 weeks, 8 weeks]
pain as VAS [12 days, 4 weeks, 8 weeks]
sleep quality (Pittsburgh Sleep Quality Index, PSQI) [12 days, 4 weeks, 8 weeks]
EORTC QLQ-C15 PAL [12 days, 4 weeks, 8 weeks]
European Organization for Research and Treatment of Cancer Quality of Life Palliative
Adverse events (AE) [up to 8 weeks]
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)
C-reactive protein (CRP) [12 days, 4 weeks, 8 weeks]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Schleswig-Holstein	Kiel	Schleswig-Holstein	Germany	24105
2	University Hospital Schleswig-Holstein	Lübeck	Schleswig-Holstein	Germany
3	Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH)	Hamburg		Germany	20246

Sponsors and Collaborators

University Hospital Schleswig-Holstein
Avextra Pharma GmbH
SocraMetrics GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Schleswig-Holstein

ClinicalTrials.gov Identifier:

NCT06097533

Other Study ID Numbers:

BELCANTO
2022-004137-39
DRKS00031009

First Posted:

Oct 24, 2023

Last Update Posted:

Oct 24, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 24, 2023