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)

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.

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.

Inclusion Criteria:

1. Written informed consent

2. Individuals of any sex, gender, sexual orientation, and ethnicity aged 18 or over

3. No previous use of Cannabis in the last 6 months

4. 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:

   1. presence of physical symptoms, such as moderate or severe pain, nausea, vomiting, loss of appetite
   2. presence of psychological symptoms, such as anxiety, depression and insomnia

5. ECOG ≤ 3

6. ESAS-TSDS score ≥ 16

7. Patients on stable therapy with "Level II" or Level III" opioids according to the WHO analgesic scale and/or with adjuvants

8. Women of childbearing age (Women Of Child Bearing Potential, WOCBP) are eligible for the study only if:

   1. Negative pregnancy test
   2. 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.

9. 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.

Exclusion Criteria:

• 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