Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT06097533
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Study:
NCT06097533
Study Brief:
Protocol Section:
NCT06097533