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

Phase 2

Recruiting

• Conditions: Oncologic patients undergoing palliative oncologic treatment.

• Registration Number: DRKS00031009
• Lead Sponsor: niversitätsklinikum Schleswig-Holstein,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

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).

Exclusion Criteria

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom change as change in ESAS-TSDS score (percent) at 12±2 days compared to baseline between THC:CBD intervention groups and placebo control group.