NCT06097533 Improvement of Quality of Life by Cannabinoids in Oncologic Patients
| NCT ID | NCT06097533 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital Schleswig-Holstein |
| Condition | Medical Oncology |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2024-04-08 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 170 participants in total. It began in 2024-04-08 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06097533 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, studying Medical Oncology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06097533 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06097533 currently recruiting?
Yes, NCT06097533 is actively recruiting participants. Contact the research team at Justus.Domschikowski@uksh.de for enrollment information.
Where is the NCT06097533 trial being conducted?
This trial is being conducted at Hamburg, Germany, Kiel, Germany, Kiel, Germany, Lübeck, Germany.
Who is sponsoring the NCT06097533 clinical trial?
NCT06097533 is sponsored by University Hospital Schleswig-Holstein. The trial plans to enroll 170 participants.