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.
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
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
Parallel
Cannabis Extract Oil
DrugCannabis extract 10:10 oil solution consisting of 10 mg/ml 9 Tetrahydrocannabinol (THC and 10 mg/ml Cannabidiol ( diluted in medium chain triglyceride oil
Placebo
Other interventionMixture of fatty oils with components according to the oil monographs of the European Pharmacopoeia
Multidimensional assessment of the state of health: Edmonton Symptom Assessment System questionnaire(ESAS)
ESAS-TSDS (Total Symptom Distress Score) is defined as the total score derived from the sum of individual ratings for each of the nine symptoms included in the ESAS questionnaire
NRS -2002 Nutrition Score Risk Screening
change from baseline (day0) to visit 4 (day 56) and longitudinal change from baseline to visit4, including values at visit1 (day 14), visit2 (day 28), visit3 (day 42)
Sleep qualit- PSQI questionnaire
PSQI global score in terms of proportion of patients with sleep disturbance and median score
Neuropathic pain - DN4 questionnaire
change from baseline to visit4 (day 56) and longitudinal change from baseline to visit4, including values at visit1 (day 14), visit2 (day 28), visit3 (day 42)
Cancer-related asthenia - BFI questionnnaire
change from baseline to visit4 (day 56) and longitudinal change from baseline to visit4, including values at visit1 (day 14), visit2 (day 28), visit3 (day 42)
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