[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628306":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":30,"responsibleParty":51,"collaborators":26,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":26,"enrollmentInfo":63,"targetDuration":26,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"National Cancer Institute, Naples","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cannabis extract","EXPERIMENTAL","balanced THC\u002FCBD extract (Cannabis extract Avextra 10\u002F10 oral solution)",[13],"Drug: Cannabis Extract Oil",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Cannabis Extract Oil","Cannabis extract 10:10 oil solution consisting of 10 mg\u002Fml 9 Tetrahydrocannabinol (THC and 10 mg\u002Fml Cannabidiol ( diluted in medium chain triglyceride oil",[9],null,{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Mixture of fatty oils with components according to the oil monographs of the European Pharmacopoeia",[15],[31],{"facility":32,"status":26,"city":33,"state":26,"zip":26,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"IRCCS Fondazione G. Pascale","Naples","Italy","IT",{"type":37,"coordinates":38},"Point",[39,40],14.26811,40.85216,{"lat":40,"lon":39},[43,48],{"name":44,"role":45,"phone":46,"phoneExt":26,"email":47},"Maria Carmela Piccirillo, MD","CONTACT","+39 08117770280","m.piccirillo@istitutotumori.na.it",{"name":49,"role":50,"phone":26,"phoneExt":26,"email":26},"Arturo Cuomo, MD","PRINCIPAL_INVESTIGATOR",{"type":52,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100628306","phase-2-cannabis-extract-in-oncology-patients-for-the-treatment-of-tumor-related-symptom-burden-100628306",false,"NCT07459920","Cannabis extrAct in Oncology Patients for the Treatment of TUmor Related Symptom Burden","Cannabis extrAct in Oncology Patients for the Treatment of TUmor Related Symptom Burden (CAPTURE)","CAPTURE","Inclusion Criteria:\n\n1. Written informed consent\n2. Individuals of any sex, gender, sexual orientation, and ethnicity aged 18 or over\n3. No previous use of Cannabis in the last 6 months\n4. 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:\n\n   1. presence of physical symptoms, such as moderate or severe pain, nausea, vomiting, loss of appetite\n   2. presence of psychological symptoms, such as anxiety, depression and insomnia\n5. ECOG ≤ 3\n6. ESAS-TSDS score ≥ 16\n7. Patients on stable therapy with \"Level II\" or Level III\" opioids according to the WHO analgesic scale and\u002For with adjuvants\n8. Women of childbearing age (Women Of Child Bearing Potential, WOCBP) are eligible for the study only if:\n\n   1. Negative pregnancy test\n   2. Willingness to use effective contraception (concurrent use of two methods with a Pearl Index \\\u003C 1%) during treatment and for at least 3 months after the last dose of the investigational product.\n9. 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.\n\nExclusion Criteria:\n\n* 1\\. Inability to understand and complete the questionnaires required by the study 2. Known hypersensitivity\u002Fallergy to THC or CBD 3. Psychiatric illness related to schizophrenia\u002Fpsychosis 4. Personal history of any type of addiction 5. Pregnancy \u002F 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","ALL","18 Years",{"count":64,"type":65},156,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","CAPTURE is a prospective, interventional, randomized, phase 2, double-blind, placebo-controlled study assessing the therapeutic add-on effect of the balanced THC\u002FCBD extract (Cannabis extract Avextra 10\u002F10 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.",[71],"Advanced Malignant Solid Tumor",[73,74,75],"TUmor Related symptom burden","Oncology patients","balanced THC\u002FCBD extract","NOT_YET_RECRUITING","2026-03-03",{"date":79,"type":80},"2026-03-10","ACTUAL",{"date":82,"type":65},"2026-04-01",{"date":84,"type":65},"2028-12-31",{"name":5,"class":6},1]