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

March 3, 2026 updated by: National Cancer Institute, Naples

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy
        • IRCCS Fondazione G. Pascale
        • Contact:
        • Principal Investigator:
          • Arturo Cuomo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cannabis extract
balanced THC/CBD extract (Cannabis extract Avextra 10/10 oral solution)
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
Placebo Comparator: Placebo
Mixture 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.
Other: Placebo
Mixture of fatty oils with components according to the oil monographs of the European Pharmacopoeia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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
PSQI global score in terms of proportion of patients with sleep disturbance and median score
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
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)
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
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)
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.
Proportion of patients requiring dose reductions, treatment delays, and discontinuation of antineoplastic treatment for reasons other than disease progression
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
Average dose of concomitant analgesic and adjuvant drugs
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
Incidence of adverse events judged by the investigator to be related to the investigational medicinal product by intensity.
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
Proportion of patients requiring discontinuation of study treatment due to toxicity and overall duration of study treatment
Intake of the investigational drug will be documented at all visits by monitoring the patient's diary up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Institute, Naples

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAPTURE
  • 2024-519568-42-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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