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

University Hospital Schleswig-Holstein (UKSH)

Status and phase: Enrolling; Phase 2

Conditions: Cannabinoids; Quality of Life; Palliative Care; Medical Oncology

Treatments: Drug: Cannabisextrakt Avextra 10/10 Lösung

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06097533

BELCANTO

2022-004137-39 (EudraCT Number)

DRKS00031009 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 170 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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170 participants in 2 patient groups, including a placebo group

Cannabisextrakt Avextra 10/10 Lösung

Experimental group

Description:

Solution with tetrahydrocannabinol and cannabidiol

Treatment:

Drug: Cannabisextrakt Avextra 10/10 Lösung

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Cannabisextrakt Avextra 10/10 Lösung