Cannabis extrAct in Oncology Patients for the Treatment of TUmor Related Symptom Burden

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute, Naples

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

Treatment groups

156 Participants
are divided into 2 treatment groups