About this trial
CAPTURE is a prospective, interventional, randomized, phase 2, double-blind, placebo-controlled study assessing the therapeutic add-on effect of the balanced THC/CBD extract (Cannabis extract Avextra 10/10 oral solution) on symptom burden in patients with advanced oncological disease receiving active treatment with WHO level II or III opioids and adjuvants therapies, compared to placebo, as measured by the Edmonton Symptom Assessment System Total Symptom Distress Score (ESAS-TSDS) at 8 weeks post randomization.
Eligibility criteria
Qualifiers
Written informed consent
Individuals of any sex, gender, sexual orientation, and ethnicity aged 18 or over
No previous use of Cannabis in the last 6 months
presence of physical symptoms, such as moderate or severe pain, nausea, vomiting, loss of appetite
Disqualifiers
1. Inability to understand and complete the questionnaires required by the study 2. Known hypersensitivity/allergy to THC or CBD 3. Psychiatric illness related to schizophrenia/psychosis 4. Personal history of any type of addiction 5. Pregnancy / breastfeeding 6. PEG feeding 7. Any other medical condition that, in the opinion of the physician, would affect the participant's safety or ability to comply with the study protocol 8. Concurrent participation in other clinical studies started less than 30 days ago
Trial design
Treatments tested in this trial
- Cannabis Extract Oil
- Placebo