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New treatment option for Medical Oncology
Official title Improvement of Quality of Life by Cannabinoids in Oncologic Patients
ClinicalTrials.gov ID: NCT06097533
What this study is testing
What is Cannabisextrakt Avextra 10/10 Lösung?
Cannabisextrakt Avextra 10/10 Lösung is an investigational medicine, being studied as a potential treatment for medical oncology.
Also referred to as Cannabisextrakt Avextra 10/10 solution.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 and older
You may be able to join if
- ≥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
You likely can't join if
- 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)
See the full eligibility 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%)
- 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-treatment studies (i.e. biomarker-studies, registries) is allowed, if the study-aim does not interfere with measures of the second...
- Any other condition as judged by the investigator, e.g. non-compliance
The study team makes the final eligibility decision.
Where it's taking place
- Hamburg, Free and Hanseatic City of Hamburg, Germany
- Kiel, Schleswig-Holstein, Germany
- Lübeck, Schleswig-Holstein, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamburg, Free and Hanseatic City of Hamburg, Germany; Kiel, Schleswig-Holstein, Germany; Lübeck, Schleswig-Holstein, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.