Improvement of Quality of Life by Cannabinoids in Oncologic Patients

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

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NCT-Nummer:
NCT06097533

Studienbeginn:
Dezember 2023

Letztes Update:
24.10.2023

Wirkstoff:
Cannabisextrakt Avextra 10/10 Lösung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Schleswig-Holstein

Collaborator:
Avextra Pharma GmbH, SocraMetrics GmbH,

Studienlocations
(3 von 3)

University Hospital Schleswig-Holstein
24105 Kiel
(Schleswig-Holstein)
Germany» Google-Maps
Ansprechpartner:
Justus Domschikowski, M.D.» Ansprechpartner anzeigen

University Hospital Schleswig-Holstein
Lübeck
(Schleswig-Holstein)
Germany» Google-Maps
Ansprechpartner:
Franziska Hamm, M.D.» Ansprechpartner anzeigen

Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH)
20246 Hamburg
(Hamburg)
Germany» Google-Maps
Ansprechpartner:
Matthias Rostock, M.D.» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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:

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)

Studien-Arme

Experimental: Cannabisextrakt Avextra 10/10 Lösung
Solution with tetrahydrocannabinol and cannabidiol
Placebo Comparator: Placebo
Sesame oil, Ph.Eur. Linseed oil, Ph.Eur

Geprüfte Regime

Cannabisextrakt Avextra 10/10 Lösung:
medical cannabinoids

Quelle: ClinicalTrials.gov

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