Improvement of Quality of Life by Cannabinoids in Oncologic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cannabisextrakt Avextra 10/10 Lösung.
- Who it may be relevant to
- Registry conditions: Medical Oncology, Palliative Care, Quality of Life, Cannabinoids. Basic parameters: from 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Improvement of Quality of Life by Cannabinoids in Oncologic Patients (BEfindLichkeitsverbesserung Unter CANnabinoid-ExtrakTen Bei Onkologischen Patienten)
Overview
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
- Drug Cannabisextrakt Avextra 10/10 Lösung
medical cannabinoids
Primary outcome measures
- ESAS-TSDS score [Time frame: 12 days]
Secondary outcome measures (12)
- Global Patient's Assessment [Time frame: 12 days, 4 weeks, 8 weeks]
- opioid dose as morphine equivalent [Time frame: 12 days, 4 weeks, 8 weeks]
- defined daily dosages (DDD) of neuropharmaceuticals [Time frame: 12 days, 4 weeks, 8 weeks]
- ESAS-TSDS score [Time frame: 4 weeks, 8 weeks]
- inappetence [Time frame: 12 days, 4 weeks, 8 weeks]
- NCCN distress thermometer [Time frame: 12 days, 4 weeks, 8 weeks]
- pain as VAS [Time frame: 12 days, 4 weeks, 8 weeks]
- sleep quality (Pittsburgh Sleep Quality Index, PSQI) [Time frame: 12 days, 4 weeks, 8 weeks]
- EORTC QLQ-C15 PAL [Time frame: 12 days, 4 weeks, 8 weeks]
- Adverse events (AE) [Time frame: up to 8 weeks]
- C-reactive protein (CRP) [Time frame: 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 [Time frame: 12 days, 4 weeks, 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Germany · 4 centers
- Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH) — Hamburg
- University Hospital Schleswig-Holstein — Kiel
- University Hospital Schleswig-Holstein — Kiel
- University Hospital Schleswig-Holstein — Lübeck
Identifiers
NCT: NCT06097533 · BELCANTO · 2022-004137-39 · DRKS00031009