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

NCT07459920 | Not Yet Recruiting Phase 2

• 2 other identifiers: CAPTURE2024-519568-42-00
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Advanced Malignant Solid Tumor

Keywords

TUmor Related symptom burden; Oncology patients; balanced THC/CBD extract

Outcome Measures

Primary Outcomes (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

  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)

• NRS -2002 Nutrition Score Risk Screening

  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

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

• Neuropathic pain - DN4 questionnaire

  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

  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

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

Study Arms (2)

Cannabis extract

EXPERIMENTAL

balanced THC/CBD extract (Cannabis extract Avextra 10/10 oral solution)

Drug: Cannabis Extract Oil

Placebo

PLACEBO COMPARATOR

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

Interventions

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

Cannabis extract

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

IRCCS Fondazione G. Pascale

Naples, Italy

Location

MeSH Terms

Interventions

nabiximols

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 10, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)