Using cannabis extract to improve quality of life in cancer patients
Improvement of Quality of Life by Cannabinoids in Oncologic Patients (BEfindLichkeitsverbesserung Unter CANnabinoid-ExtrakTen Bei Onkologischen Patienten)
This study is testing if a cannabis extract can help improve the quality of life for cancer patients receiving palliative care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 25 Years and up |
| Sex | All |
| Sponsor | University Hospital Schleswig-Holstein Academic / other |
| Locations | 4 sites (Hamburg, Free and Hanseatic City of Hamburg and 3 other locations) |
| Trial ID | NCT06097533 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the cannabis extract Avextra 10/10 in reducing symptom burden and enhancing the well-being of patients undergoing palliative care for cancer. A total of 170 participants will be randomly assigned to receive either the cannabis extract or a placebo over a period of 12±2 days. The primary outcome will be measured using the Edmonton Symptom Assessment System total symptom distress score, with additional assessments of quality of life and other parameters at multiple time points. The study seeks to contribute to evidence-based medicine in palliative care, particularly for elderly and severely ill patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 25 and older who are receiving palliative oncological therapy and have a significant symptom burden.
Not a fit: Patients with severe nausea or vomiting, those who have used cannabis recently, or individuals with certain contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option to significantly improve the quality of life for patients with advanced cancer.
How similar studies have performed: Other studies have shown promising results with cannabinoid therapies in palliative care, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hamburg, Free and Hanseatic City of Hamburg and 3 other locations
- Hubertus Wald Tumorzentrum Universitäres Cancer Center Hamburg (UCCH) — Hamburg, Free and Hanseatic City of Hamburg, Germany (Recruiting)
- University Hospital Schleswig-Holstein — Kiel, Schleswig-Holstein, Germany (Recruiting)
- University Hospital Schleswig-Holstein — Kiel, Schleswig-Holstein, Germany (Recruiting)
- University Hospital Schleswig-Holstein — Lübeck, Schleswig-Holstein, Germany (Recruiting)
Study contacts
- Study coordinator: Justus Domschikowski, M.D.
- Email: Justus.Domschikowski@uksh.de
- Phone: 0431500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.