Improvement of well-being under Cannabinoid extracts in palliative oncology patients. - BELCANTO

niversitätsklinikum Schleswig-Holstein,0 个研究点目标入组 170 人开始时间: 2024年1月29日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Palliative oncological therapy
•- Eastern Cooperative Oncology Group (ECOG) status 1, 2, or 3 and no longer able to work
•- Edmonton Symptom Assessment System (ESAS) total symptom distress score (TSDS) > 15
•- Nutrition Risk Score > 3 (Kondrup et al., 2003)
•- Pain numerical rating scale > 3
•- Written informed consent after detailed explanation of the conduct and risks of the planned study (informed consent)
•- For women of childbearing age (WOCBP)
•o Negative pregnancy test
•o Safe contraception (Pearl Index < 1%) of pregnancy (ovulation inhibitors, heterosexual abstinence, menopause, vasectomized partner, bilateral tubal occlusion, or combination of two less safe methods).

•- Nausea/vomiting (exclusion criterion only).
•- Inability to understand and complete the questionnaires
•- Cannabis use in the last 2 years
•- Alcohol dependence
•- Pregnancy/breastfeeding
•- Contraindications or intolerance of study medication (see Tab. 1), especially psychoses
•- Simultaneous participation in other clinical studies (verification by self-report)
•- Any other condition that, in the opinion of the responsible investigator, makes the subject unsuitable for participation in the study, e.g. (expected) poor communication skills or compliance

发起方

niversitätsklinikum Schleswig-Holstein,