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NCT Number: NCT07459920

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

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.

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Key information

Conditions

Advanced Malignant Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IRCCS Fondazione G. Pascale

Naples, Italy

Location contact

Arturo Cuomo, MD

PRINCIPAL_INVESTIGATOR

Maria Carmela Piccirillo, MD

CONTACT

[email protected]

+39 08117770280

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cannabis Extract Oil

Drug

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

Placebo

Other

Mixture of fatty oils with components according to the oil monographs of the European Pharmacopoeia

Primary outcomes

  1. 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

    ESAS-TSDS (Total Symptom Distress Score) is defined as the total score derived from the sum of individual ratings for each of the nine symptoms included in the ESAS questionnaire

Secondary outcomes

  1. 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

    change from baseline (day0) to visit 4 (day 56) and longitudinal change from baseline to visit4, including values at visit1 (day 14), visit2 (day 28), visit3 (day 42)

  2. 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

    PSQI global score in terms of proportion of patients with sleep disturbance and median score

  3. 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

    change from baseline to visit4 (day 56) and longitudinal change from baseline to visit4, including values at visit1 (day 14), visit2 (day 28), visit3 (day 42)

  4. 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

    change from baseline to visit4 (day 56) and longitudinal change from baseline to visit4, including values at visit1 (day 14), visit2 (day 28), visit3 (day 42)

  5. Antineoplastic therapies

    Time frame: Antineoplastic drugs are documented at all visits up to 2 months.

    Proportion of patients requiring dose reductions, treatment delays, and discontinuation of antineoplastic treatment for reasons other than disease progression

  6. Concomitant medications

    Time frame: Concomitant medications are documented at all visits up to 2 months

    Average dose of concomitant analgesic and adjuvant drugs

  7. 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

    Incidence of adverse events judged by the investigator to be related to the investigational medicinal product by intensity.

  8. 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

    Proportion of patients requiring discontinuation of study treatment due to toxicity and overall duration of study treatment

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Naples

Other

Registry information

Official study title

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

Acronym: CAPTURE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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