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

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: Not yet recruiting
• Conditions: Advanced Malignant Solid Tumor
• Intervention / Treatment: Drug: Cannabis Extract Oil; Other: Placebo

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: Interventional
• Enrollment (Estimated): 156
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy
    • IRCCS Fondazione G. Pascale
    • Contact: Maria Carmela Piccirillo, MD; Phone Number: +39 08117770280; Email: m.piccirillo@istitutotumori.na.it
    • Principal Investigator: Arturo Cuomo, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	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

Outcome Measure	Measure Description	Time Frame
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)	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	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	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	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	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	Average dose of concomitant analgesic and adjuvant drugs	Concomitant medications are documented at all visits up to 2 months
adverse events	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	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

• Sponsor: National Cancer Institute, Naples

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: TUmor Related symptom burden; Oncology patients; balanced THC/CBD extract
• Additional Relevant MeSH Terms: nabiximols
• Other Study ID 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