Not Yet RecruitingPhase 2

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

Italy156 participantsStarted 2026-04-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

Multidimensional assessment of the state of health: Edmonton Symptom Assessment System questionnaire(ESAS)

Timeframe: The ESAS questionnaire will be completed at baseline (day0), at visit1 (day 14), at visit2 (day 28), visit3 (day 42) and visit4 (day52) up to 2 months

Trial details

NCT IDNCT07459920

SponsorNational Cancer Institute, Naples

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-01

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