DRONABINOL, CANNABIDIOL for Advanced cancer

Inclusion criteria

• {"criterion_text":"- 1. Written informed consent\n- 2. Individuals of any sex, gender, sexual orientation, and ethnicity aged 18 years or older\n- 3. No prior use of cannabis within the past 6 months\n- 4. Patients with advanced oncologic disease, life expectancy of at least 6 months, currently undergoing active antineoplastic treatment, and experiencing a clinically relevant impairment in quality of life, defined by the presence of at least one of the following: a. Physical symptoms such as moderate to severe pain, nausea, vomiting, anorexia, or fatigue b. Psychological symptoms such as anxiety, depression, or insomniaù\n- 5. PS ECOG ≤ 3\n- 6. ESAS-TSDS score ≥ 16\n- 7. Patients on stable therapy with opioids classified as \"Level II\" or \"Level III\" according to the WHO analgesic scale and/or receiving adjuvant medications\n- 8. Women of Childbearing Potential (WOCBP) are eligible for the study only if: a. Negative pregnancy test b. Requirement to use effective contraception (defined as the use of two methods with a Pearl Index < 1%)"}

Exclusion criteria

• {"criterion_text":"- 1. Inability to understand and complete the questionnaires\n- 2. Known hypersensitivity/allergy to THC or CBD\n- 3. Psychiatric disorders related to schizophrenia or psychosis\n- 4. Personal history of any type of substance abuse or addiction\n- 5. Pregnancy or breastfeeding\n- 6. Feeding via percutaneous endoscopic gastrostomy (PEG)\n- 7. Any other clinical condition that, in the investigator's judgment, could compromise the participant's safety or their ability to adhere to the study protocol.\n- 8. Participation in other clinical trials within the past 30 days"}

Primary endpoints

• {"endpoint_text":"- ESAS-TSDS, defined as the total score derived from the sum of individual ratings for each of the nine symptoms included in the ESAS questionnaire.","definition_or_measurement_approach":"Defined as the total score derived from the sum of individual ratings for each of the nine symptoms included in the ESAS questionnaire."}

Secondary endpoints

• {"endpoint_text":"- 1. NRS-2002 (Nutrition Risk Screening) score\n- 2. Global Pittsburgh Sleep Quality Index (PSQI) score, reported as both the proportion of patients with sleep disturbances and the median total score\n- 3. Douleur Neuropathique 4 (DN4) questionnaire score, reported as the proportion of patients with neuropathic pain and the median total score\n- 4. Brief Fatigue Inventory (BFI) score\n- 5. ESAS subscores at 8 weeks\n- 6. Proportion of responders based on ESAS-TSDS at 8 weeks\n- 7. Proportion of patients requiring","definition_or_measurement_approach":"1. NRS-2002: Nutrition Risk Screening score\n2. PSQI: global score and proportion with sleep disturbances; median total score reported\n3. DN4: questionnaire score; proportion with neuropathic pain and median total score\n4. BFI: Brief Fatigue Inventory score\n5. ESAS subscores assessed at 8 weeks\n6. ESAS-TSDS responder rate at 8 weeks\n7. Text truncated in source (listed as 'Proportion of patients requiring' without completion)"}

Italy

Earliest CTIS Part Ii Submission Date

28-07-2025

Latest Decision Or Authorization Date

23-12-2025

Processing Time Days

148

Number Of Sites

1

Number Of Participants

156

Primary sponsor

Full Name

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"Avextra Pharma GmbH","duties_or_roles":"Source of monetary support","organisation_type":""}