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

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ClinicalTrials.gov Identifier: NCT06097533
Recruitment Status : Not yet recruiting
First Posted : October 24, 2023
Last Update Posted : October 24, 2023
Sponsor:
Collaborators:
Avextra Pharma GmbH
SocraMetrics GmbH
Information provided by (Responsible Party):
University Hospital Schleswig-Holstein

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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)
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)
Estimated Study Start Date : December 1, 2023
Estimated Primary Completion Date : November 30, 2026
Estimated Study Completion Date : November 30, 2026
Arms and Interventions
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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
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Primary Outcome Measures :
  1. ESAS-TSDS score [ Time Frame: 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 :
  1. Global Patient's Assessment [ Time Frame: 12 days, 4 weeks, 8 weeks ]
  2. opioid dose as morphine equivalent [ Time Frame: 12 days, 4 weeks, 8 weeks ]
  3. defined daily dosages (DDD) of neuropharmaceuticals [ Time Frame: 12 days, 4 weeks, 8 weeks ]
  4. ESAS-TSDS score [ Time Frame: 4 weeks, 8 weeks ]
  5. inappetence [ Time Frame: 12 days, 4 weeks, 8 weeks ]
  6. NCCN distress thermometer [ Time Frame: 12 days, 4 weeks, 8 weeks ]
  7. pain as VAS [ Time Frame: 12 days, 4 weeks, 8 weeks ]
  8. sleep quality (Pittsburgh Sleep Quality Index, PSQI) [ Time Frame: 12 days, 4 weeks, 8 weeks ]
  9. EORTC QLQ-C15 PAL [ Time Frame: 12 days, 4 weeks, 8 weeks ]
    European Organization for Research and Treatment of Cancer Quality of Life Palliative

  10. Adverse events (AE) [ Time Frame: 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)

  11. C-reactive protein (CRP) [ Time Frame: 12 days, 4 weeks, 8 weeks ]
  12. 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 [ Time Frame: 12 days, 4 weeks, 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06097533


Locations
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Germany
University Hospital Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Justus Domschikowski, M.D.         
University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Contact: Franziska Hamm, M.D.         
Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH)
Hamburg, Germany, 20246
Contact: Matthias Rostock, M.D.         
Sponsors and Collaborators
University Hospital Schleswig-Holstein
Avextra Pharma GmbH
SocraMetrics GmbH
More Information
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Responsible Party: University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT06097533    
Other Study ID Numbers: BELCANTO
2022-004137-39 ( EudraCT Number )
DRKS00031009 ( Registry Identifier: German Clinical Trials Register )
First Posted: October 24, 2023    Key Record Dates
Last Update Posted: October 24, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Aggregated data can be shared. Individual data only after internal and IRB review.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No