INTERVENTIONALNOT YET RECRUITINGNCT07459920

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-03-10

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2
Enrollment: 156 (ESTIMATED)
Start date: 2026-04-01
Sponsor: National Cancer Institute, Naples
Design: RANDOMIZED · PARALLEL · SUPPORTIVE CARE
Locations: 1
Results record: Not present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

No governed compound link was found.

Medicines

No exact medicine-name link was found.

Interventions

What was registered

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

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: Not reported
Healthy volunteers: Not accepted

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

primary outcomes

primary 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

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

secondary measures

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)

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

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)

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)

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

Concomitant medications

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

Average dose of concomitant analgesic and adjuvant drugs

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.

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

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 86f67db9-6dcb-40bb-ab92-9c38aef18962
Retrieved: 11/09/2026, 14:14:52
SHA-256: ed7949e74ec2ffff54e0736d5a729ee55002f7bdb9463215da2ee36292fed39e