Improvement of Quality of Life by Cannabinoids in Oncologic Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Medical Oncology, Palliative Care, Quality of Life, Cannabinoids

Intervention / Treatment
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* Drug: Cannabisextrakt Avextra 10/10 Lösung


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabisextrakt Avextra 10/10 Lösung<br>Solution with tetrahydrocannabinol and cannabidiol | Drug: Cannabisextrakt Avextra 10/10 Lösung<br>* medical cannabinoids<br>|
| Placebo Comparator: Placebo<br>Sesame oil, Ph.Eur. Linseed oil, Ph.Eur | Drug: Cannabisextrakt Avextra 10/10 Lösung<br>* medical cannabinoids<br>|

What is the study measuring?
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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 |
| --- | --- | --- |
| Global Patient's Assessment |  | 12 days, 4 weeks, 8 weeks | 
| 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 | 
| 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 | 
| sleep quality (Pittsburgh Sleep Quality Index, PSQI) |  | 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 |