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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Advanced Malignant Solid Tumor

In brief

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.

Key facts

Study ID

NCT07459920

Run by

National Cancer Institute, Naples

People needed

156

Starts

2026-04-01

Expected to finish

2028-12-31

Last updated by the study team

2026-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Patients with advanced oncological neoplasia with a life expectancy of at least 6 months on active antineoplastic treatment and with a compromised quality of life defined by at least one of the following criteria:
• presence of physical symptoms, such as moderate or severe pain, nausea, vomiting, loss of appetite
• presence of psychological symptoms, such as anxiety, depression and insomnia
• ECOG ≤ 3
• ESAS-TSDS score ≥ 16
• Patients on stable therapy with "Level II" or Level III" opioids according to the WHO analgesic scale and/or with adjuvants
• Women of childbearing age (Women Of Child Bearing Potential, WOCBP) are eligible for the study only if:
• Negative pregnancy test
• Willingness to use effective contraception (concurrent use of two methods with a Pearl Index < 1%) during treatment and for at least 3 months after the last dose of the investigational product.
• Male participants with partners of childbearing potential must agree to use condoms (with spermicide, if available) in combination with an additional highly effective contraceptive method used by their partner, during treatment period and for at least 3 months after the last dose of the investigational product.

You may not qualify if…

• 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

Where it is running

• IRCCS Fondazione G. Pascale — Naples, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.