RecruitingPhase 2NCT06097533

Improvement of Quality of Life by Cannabinoids in Oncologic Patients

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

Sponsor

University Hospital Schleswig-Holstein

Enrollment

170 participants

Start Date

Apr 8, 2024

Study Type

INTERVENTIONAL

Conditions

Quality of Life Palliative Care Medical Oncology Cannabinoids

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.

Eligibility

Min Age: 25 Years

Inclusion Criteria10

≥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 Criteria8

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

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