Improvement of Quality of Life by Cannabinoids in Oncologic Patients (BELCANTO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Palliative Care; Medical Oncology; Cannabinoids
• Intervention / Treatment: Drug: Cannabisextrakt Avextra 10/10 Lösung

Detailed Description

170 oncological patients in palliative treatment will be randomized 1:1 to an THC:CBD-interventional arm and an placebo-arm. At the timepoints baseline, 12±2 days, 18±3 days, four weeks and eight weeks, the global burden of symptoms (ESAS TSDS), quality of life (EORTC QLQ C15 PAL) and other parameter will be measured and the intraindividual difference in comparison with the baseline will be compared between the groups. This study is intended to provide a significant contribution to Evidence-based medicine (EbM) of CAM in palliative medicine as well as for elderly and severely ill subjects (resp.) in general.

The following gain of knowledge is expected:

• substancial and reliable effects of CAM in elderly subjects being in a multimorbid and psychologically very stressful situation of illness and life (resp.).
• substancial and reliable effects of CAM in aduld subjects being in a oncologically and palliative situation of illness and life (resp.).
• compatibility of a CAM-therapy in multimorbid patients with polypharmacotherapy.
• importance of CAM for the very frequent psychovegetative disturbance and comorbidities of many illnesses like sleepnesness, loss of appetite, nausea, fear and affective disturbance.
• possible reduction of costs and improved economics through CAM

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Justus Domschikowski, M.D.; Phone Number: 26511 0431500; Email: Justus.Domschikowski@uksh.de
• Study Contact Backup: Name: Thomas Herdegen, Prof.; Phone Number: 30402 0431500; Email: Thomas.Herdegen@uksh.de

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH)
    • Contact: Matthias Rostock, M.D.; Phone Number: 52490 +4940 7410; Email: m.rostock@uke.de
    • Contact: Marianne Sinn, M.D.; Email: ma.sinn@uke.de
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Recruiting
      • University Hospital Schleswig-Holstein
      • Contact: Anne Letsch, Prof.; Phone Number: 22510 0431500; Email: Anne.Letsch@uksh.de
      • Contact: Bjoern N Heydrich, M.D.; Phone Number: 22513 0431500; Email: Bjoern.Heydrich@uksh.de
    • Lübeck, Schleswig-Holstein, Germany
      • Recruiting
      • University Hospital Schleswig-Holstein
      • Contact: Franziska Hamm, M.D.; Phone Number: 44195 0451 500; Email: AnnaFranziska.Hamm@uksh.de
      • Contact: Kim Luley, M.D.; Email: Kim.Luley@uksh.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥25 years old and legally competent
• Palliative oncological therapy
• ECOG status 1, 2 or 3, incapacitated for work
• ESAS TSDS > or equals 16
• Nutritional Risk Screening > or equals 3
• Pain numerical rating scale > or equals 4
• informed consent

• for WOCBP:

  • Negative pregnancy test
  • Reliable contraception (Pearl Index < 1%)

Exclusion Criteria:

• nausea > or equals grade 3 (CTCAE) or vomiting > or equals grade 2 (CTCAE) in the preceding week
• Inability to understand and complete the questionnaires
• Cannabis use in the last 6 weeks
• Alcohol addiction
• Pregnancy/lactation
• Contraindications or intolerance to the study medication (esp. psychosis)
• Simultaneous participation in other clinical studies (sumulataneous participation in non-interventional studies (i.e. biomarker-studies, registries) is allowed, if the study-aim does not interfere with measures of the second study)
• Any other condition as judged by the investigator, e.g. non-compliance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid dose as morphine equivalent		12 days, 4 weeks, 8 weeks
defined daily dosages (DDD) of neuropharmaceuticals		12 days, 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
EORTC QLQ-C15 PAL	European Organization for Research and Treatment of Cancer Quality of Life Palliative	12 days, 4 weeks, 8 weeks
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
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
Global Patient's Assessment	Scale to evaluate the absolute severity and the change in comparison with the preceding measurement	12 days, 4 weeks, 8 weeks
ESAS-TSDS score	Edmonton Symptom Assessment System	4 weeks, 8 weeks
sleep quality (Pittsburgh Sleep Quality Index, PSQI)	contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available)	12 days, 4 weeks, 8 weeks

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Collaborators: SocraMetrics GmbH; Avextra Pharma GmbH

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: BELCANTO
• Other Study ID Numbers: BELCANTO; 2022-004137-39 (EudraCT Number); DRKS00031009 (Registry Identifier: German Clinical Trials Register)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Aggregated data can be shared. Individual data only after internal and IRB review.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No