Cannabinoids, Medical Oncology, Palliative Care, Quality of Life
Conditions
Keywords
BELCANTO
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.
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
Interventions
DRUGCannabisextrakt Avextra 10/10 Lösung
medical cannabinoids
Sponsors
Avextra Pharma GmbH
SocraMetrics GmbH
University Hospital Schleswig-Holstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
IMPs are centrally blinded and randomised at the pharmacy.
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)
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Edmonton Symptom Assessment System |
| inappetence | 12 days, 4 weeks, 8 weeks | — |
| NCCN distress thermometer | 12 days, 4 weeks, 8 weeks | — |
| Global Patient's Assessment | 12 days, 4 weeks, 8 weeks | Scale to evaluate the absolute severity and the change in comparison with the preceding measurement |
| sleep quality (Pittsburgh Sleep Quality Index, PSQI) | 12 days, 4 weeks, 8 weeks | contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available) |
| 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 | — |
| pain as VAS | 12 days, 4 weeks, 8 weeks | — |
Countries
Germany
Contacts
Primary ContactJustus Domschikowski, M.D.
Backup ContactThomas Herdegen, Prof.
Outcome results
None listed