NCT07459920

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Secondary objectives are: to assess the impact of the therapeutic add-on of a balanced THC/CBD extract (Avextra 10/10 oral solution) compared to placebo, in terms of: nutritional status, sleep quality, neuropathic pain, functional interference, severity of clinical symptoms assessed by ESAS sub scores and ESAS-TSDS response rate at 8 weeks.

Conditions

• Advanced Malignant Solid Tumor

Interventions

Type	Name	Description
DRUG	Cannabis Extract Oil	Cannabis extract 10:10 oil solution consisting of 10 mg/ml 9 Tetrahydrocannabinol (THC and 10 mg/ml Cannabidiol ( diluted in medium chain triglyceride oil
OTHER	Placebo	Mixture of fatty oils with components according to the oil monographs of the European Pharmacopoeia

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-01-01
• Completion: 2028-12-31
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: Italy