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

Phase 2Not Yet RecruitingNCT07459920

National Cancer Institute, Naples156 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

156

Conditions

Advanced Malignant Solid Tumor

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

IRCCS Fondazione G. Pascale

Naples, Italy

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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)

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

Sleep qualit- PSQI questionnaire

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

Time frame: 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)

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

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)

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.