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Advanced Malignant Solid TumorPhase 2CAPTURENCT07459920

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

A Phase 2 study testing Cannabis Extract Oil in people with Advanced Malignant Solid Tumor, run by National Cancer Institute, Naples at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignant Solid Tumor
What is being tested?
Cannabis Extract Oil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
156 participants
Where
1 siteItaly
Study dates
1 Apr 2026to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site

  • IRCCS Fondazione G. Pascale

    Naples

    Maria Carmela Piccirillo, MD, +39 08117770280, m.piccirillo@istitutotumori.na.it

    Arturo Cuomo, MD

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Cannabis Extract Oil, Placebo
Keywords
TUmor Related symptom burden, Oncology patients, balanced THC/CBD extract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cannabis Extract OilDrug

    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

  • PlaceboOther

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

Study groups in NCT07459920
Study groupRoleWhat they receive
Cannabis extractExperimentalbalanced THC/CBD extract (Cannabis extract Avextra 10/10 oral solution)
Receives: Drug: Cannabis Extract Oil
PlaceboPlacebo comparatorMixture of fatty oils with components according to the oil monographs of the European Pharmacopoeia with external appearance of the package, color, odor, density of the solution, corresponding to those of the active medicinal drug.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: 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 outcomes (8)

  1. NRS -2002 Nutrition Score Risk Screening

    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)

    Measured: The NRS will be assessed at baseline (day0), at visit1 (day 14), at visit2 (day 28), visit3 (day 42)up to 2 months

  2. Sleep qualit- PSQI questionnaire

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

    Measured: The PSQI questionnaire will be completed at baseline, visit2 (day 28) and visit4 (day 56) up to 2 months

  3. Neuropathic pain - DN4 questionnaire

    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)

    Measured: 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

  4. Cancer-related asthenia - BFI questionnnaire

    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)

    Measured: 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

  5. Antineoplastic therapies

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

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

  6. Concomitant medications

    Average dose of concomitant analgesic and adjuvant drugs

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

  7. adverse events

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

    Measured: 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

  8. treatment compliance

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

    Measured: Intake of the investigational drug will be documented at all visits by monitoring the patient's diary up to 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07459920
Sponsor's protocol ID
CAPTURE
Other IDs
2024-519568-42-00
Acronym
CAPTURE
Status last verified
Mar 2026
First submitted
2 Mar 2026
Last updated
10 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cannabis Extract Oil in people with Advanced Malignant Solid Tumor, run by National Cancer Institute, Naples at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07459920.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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