[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605817":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":46,"responsibleParty":65,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":32,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":32,"enrollmentInfo":80,"targetDuration":32,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":48,"whyStopped":32,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Fox Chase Cancer Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Cannabidiol (CBD)","EXPERIMENTAL","Participants receive hemp-derived cannabidiol (CBD) capsules in addition to standard oxaliplatin-based chemotherapy.",[13,14],"Drug: Cannabidiol (CBD)","Drug: oxaliplatin-based chemotherapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard of Care","ACTIVE_COMPARATOR","Participants receive standard oxaliplatin-based chemotherapy without CBD supplementation",[14],[21,28],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Oral hemp-derived CBD capsules, 150 mg twice daily (with titration in Cycle 1; dose reductions permitted for tolerability). Administered starting the day before oxaliplatin infusion and continued for 7 days after each chemotherapy cycle.",[9],[26,27],"hemp-derived cannabidiol","CBD capsules",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"oxaliplatin-based chemotherapy","Standard of care oxaliplatin-based regimens per NCCN guidelines (e.g., FOLFOX or CAPEOX), administered in 2-3 week cycles for a maximum of 6 months.",[9,16],null,[34],{"name":35,"affiliation":5,"role":36},"Namrata Vijayvergia, MD","PRINCIPAL_INVESTIGATOR",[38,42],{"name":35,"role":39,"phone":40,"phoneExt":32,"email":41},"CONTACT","2152141676","Namrata.Vijayvergia@fccc.edu",{"name":43,"role":39,"phone":44,"phoneExt":32,"email":45},"Henkel Valentine, PhD","2152141600","henkel.valentine@fccc.edu",[47],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Philadelphia","Pennsylvania","19111","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-75.16362,39.95238,{"lat":58,"lon":57},[61],{"name":62,"role":39,"phone":63,"phoneExt":32,"email":64},"Namrata Vijayvergia","215-214-1676","namrata.vijayvergia@fccc.edu",{"type":66,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[68],{"name":69,"class":70},"National Cancer Institute (NCI)","NIH","100605817","early-phase-1-neuroprotective-potential-of-cannabidiol-cbd-in-preventing-oxaliplatin-ox-induced-neuropathy-100605817",false,"NCT07167446","Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy","Exploring the Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy: A Prospective Study","Inclusion Criteria:\n\n1. Patients with metastatic, locally advanced unresectable colorectal cancer patients planned to receive Ox based chemotherapy in metastatic setting (at least 3 months planned).\n2. Subjects are allowed to have one cycle of Ox based chemotherapy before enrollment.\n3. ECOG PS 0-2\n4. No prior platinum exposure\n5. No evidence of ongoing neuropathy of any grade at the time of enrollment\n6. Patients must have marrow and organ function appropriate for systemic therapy, as per physician's discretion, but liver function should meet criteria below:\n\n   1. Total Bilirubin: less than and\u002For equal to 1.5 X ULN\n   2. AST(SGOT)\u002FALT(SGPT): less than and\u002For equal to 3 X ULN (5 X ULN in patients with liver metastases\n7. Ability to understand and willingness to sign a written informed consent and HIPAA consent document.\n\n   Exclusion Criteria:\n8. Family history of genetic\u002Ffamilial neuropathy and personal history of ongoing neuropathy (any grade) or nervous system disease with the potential to affect cognition, Parkinson's disease, or multiple sclerosis.\n9. Routine use of recreational marijuana products (defined as \\> 4 times per month) or illicit drug use per self-reported history within the last 90 days. If using medical cannabis products, it should be stopped at least 1 week prior to inclusion.\n10. Known underlying liver disease (Child-Pugh B or C) or baseline elevation of total bilirubin greater than and\u002For equal to 1.5 x upper limit of normal based on screening laboratory values.\n11. 1Untreated brain metastases (can increase seizure risk), or treated brain metastases on anti-seizure medications.\n12. Patients being treated with anti-seizure or anti-psychotic medications. Patients with a prior history of anti-seizure medication use, who have been off treatment for more than 3 months, are eligible. Use of Selective Serotonin Reuptake Inhibitors (SSRIs) is permitted.\n13. Concomitant treatment with strong inducers of CYP3A4 and\u002For strong inducers of CYP2C19.\n14. Underlying history of epilepsy\u002Frecurrent seizure disorder or unexplained seizure within past 6 months.\n15. Patients with current or lifetime diagnosis of schizophrenia spectrum disorder, psychotic disorder, bipolar disorder type I \\& II, cluster B personality disorders (antisocial, borderline, narcissistic, histrionic), eating disorders, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised (DSM-5-TR, APA 2022)\n16. Recent history or clinical concern for major depression with suicidal ideation as determined by investigator assessment at baseline\n17. Currently taking medications known to be contraindicated with Epidiolex -FDA-approved CBD (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, teriflunomide, clobazam, lamotrigine, valproate).\n18. Women who are pregnant or breastfeeding, and individuals of any sex who are capable of reproduction and unwilling to use an effective form of birth control (e.g., condoms, diaphragm, birth control pills, or IUD).\n19. Patients may not be receiving any other investigational agents.","ALL","18 Years",{"count":81,"type":82},30,"ESTIMATED","INTERVENTIONAL",[85],"EARLY_PHASE1","This is a pilot, prospective, randomized study evaluating the feasibility and acceptability of incorporating hemp-derived cannabidiol (CBD) supplementation to prevent oxaliplatin-induced peripheral neuropathy (OIPN) in patients receiving oxaliplatin-based chemotherapy for colorectal cancer (CRC). Participants will be randomized to receive either CBD capsules in addition to standard therapy or standard therapy alone.",[88,89,90],"Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients","Metastatic Colorectal Cancer (CRC)","Peripheral Neuropathy Due to Chemotherapy",[92,9,93,94],"Oxaliplatin-Induced Peripheral Neuropathy (OIPN)","Colorectal Cancer (CRC)","Neuroprotection","2025-10-20",{"date":97,"type":98},"2025-10-22","ACTUAL",{"date":100,"type":98},"2025-10-14",{"date":102,"type":82},"2028-09-07",{"name":5,"class":6},1]