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

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• Multidimensional assessment of the state of health: Edmonton Symptom Assessment System questionnaire(ESAS) [Time frame: 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]

Secondary outcome measures (8)

• NRS -2002 Nutrition Score Risk Screening [Time frame: The NRS will be assessed at baseline (day0), at visit1 (day 14), at visit2 (day 28), visit3 (day 42)up to 2 months]
• Sleep qualit- PSQI questionnaire [Time frame: The PSQI questionnaire will be completed at baseline, visit2 (day 28) and visit4 (day 56) up to 2 months]
• Neuropathic pain - DN4 questionnaire [Time frame: The DN4 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]
• Cancer-related asthenia - BFI questionnnaire [Time frame: The BFI 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]
• Antineoplastic therapies [Time frame: Antineoplastic drugs are documented at all visits up to 2 months.]
• Concomitant medications [Time frame: Concomitant medications are documented at all visits up to 2 months]
• adverse events [Time frame: Adverse events, their severity and relationship to the investigational medicinal product will be documented at all visits (according to the CTC-AE system) up to 2 months]
• treatment compliance [Time frame: Intake of the investigational drug will be documented at all visits by monitoring the patient's diary up to 2 months]

Eligibility criteria

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
• 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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Italy · 1 center

• IRCCS Fondazione G. Pascale — Naples

Identifiers

NCT: NCT07459920 · CAPTURE · 2024-519568-42-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗