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Improvement of Quality of Life by Cannabinoids in Oncologic Patients (BELCANTO)
EU CTIS ID: 2024-518917-24-00
What this study is testing
Proof of improvement of global symptom-burden in comparison to placebo-controlgroup in a timeframe of 12 +/- days, measured by a comparison of the Edmonton Symptom Assessment System total symptom distress score (ESAS TSDS) –rating at the time of study-start and after 12 +/- 2 days. The results of the clinical trial shall generate evidence for the use of Cannabisextract Avextra 10/10 solution in palliative oncology an das a basis for planning future trials in this field.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 25 years or older and legally able
- palliative-oncological therapy
- ECOG status 1, 2 or 3, unable to work
- Nutritional Risk Screening ≥ 3
- Pain numerical rating scale ≥ 4
- informed consent
You likely can't join if
- Sickness ≥ grade 3 (CTCAE) or vomitting ≥ grad 2 (CTCAE) in preceding week (exclusioncriterium only)
- Disability to understand and fill out the questionaires
- Use of cannabis in the last 6 months
- alcoholaddiction
- pregnancy/ breastfeeding
- contraindicationen or intolerance of IMP
See the full eligibility criteria
- 25 years or older and legally able
- palliative-oncological therapy
- ECOG status 1, 2 or 3, unable to work
- Nutritional Risk Screening ≥ 3
- Pain numerical rating scale ≥ 4
- informed consent
- if WOCBP: negative pregnancytest, safe contraception (Pearl Index < 1%)
- ESAS TSDS (item 1-8) ≥ 16
- Sickness ≥ grade 3 (CTCAE) or vomitting ≥ grad 2 (CTCAE) in preceding week (exclusioncriterium only)
- Disability to understand and fill out the questionaires
- Use of cannabis in the last 6 months
- alcoholaddiction
- pregnancy/ breastfeeding
- contraindicationen or intolerance of IMP
- bloodpressure systolic <100 mgHg or diastolic <60 mmHg
- simultaneous participation in other clinical trials; participation in non-interventional trials is in general allowed
- Any other condition due to judgement of investigator (i.e. Non-Compliance)
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.