[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520970":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":70,"centralContacts":74,"locations":80,"responsibleParty":107,"collaborators":109,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":39,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":39,"enrollmentInfo":122,"targetDuration":39,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":39,"overallStatus":83,"whyStopped":39,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"University of Southern California","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm I (C3 Complex\u002FBioperine)","EXPERIMENTAL","Patients receive C3 complex\u002FBioperine PO BID for 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy at baseline and follow up, and collection of blood samples throughout the trial.",[13,14,15,16,17,18],"Procedure: Biospecimen Collection","Procedure: Bone Marrow Aspiration","Procedure: Bone Marrow Biopsy","Dietary Supplement: Curcumin\u002F Demethoxycurcumin\u002FBisdemethoxycurcumin-containing Supplement","Dietary Supplement: Piperine Extract (Standardized)","Other: Questionnaire Administration",{"label":20,"type":21,"description":22,"interventionNames":23},"Arm II (placebo)","PLACEBO_COMPARATOR","Patients receive placebo PO BID for 12 months in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspiration and biopsy at baseline and follow up, and collection of blood samples throughout the trial.",[13,14,15,24,18],"Drug: Placebo Administration",[26,35,40,47,54,60,66],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","Biospecimen Collection","Undergo collection of blood samples",[9,20],[32,33,34],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Bone Marrow Aspiration","Undergo bone marrow aspiration",[9,20],null,{"type":27,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Bone Marrow Biopsy","Undergo bone marrow biopsy",[9,20],[45,46],"Biopsy of Bone Marrow","Biopsy, Bone Marrow",{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"DIETARY_SUPPLEMENT","Curcumin\u002F Demethoxycurcumin\u002FBisdemethoxycurcumin-containing Supplement","Given PO",[9],[53],"Curcumin C3 Complex",{"type":48,"name":55,"description":50,"armGroupLabels":56,"otherNames":57},"Piperine Extract (Standardized)",[9],[58,59],"Bioperine","Standardized Piperine Extract",{"type":61,"name":62,"description":50,"armGroupLabels":63,"otherNames":64},"DRUG","Placebo Administration",[20],[65],"Sugar pills",{"type":6,"name":67,"description":68,"armGroupLabels":69,"otherNames":39},"Questionnaire Administration","Ancillary studies",[9,20],[71],{"name":72,"affiliation":5,"role":73},"Casey L O'Connell, MD","PRINCIPAL_INVESTIGATOR",[75],{"name":76,"role":77,"phone":78,"phoneExt":39,"email":79},"Christine Duran","CONTACT","323-865-0371","duran_c@med.usc.edu",[81,99],{"facility":82,"status":83,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Los Angeles General Medical Center","RECRUITING","Los Angeles","California","90033","United States","US",{"type":90,"coordinates":91},"Point",[92,93],-118.24368,34.05223,{"lat":93,"lon":92},[96,97],{"name":76,"role":77,"phone":78,"phoneExt":39,"email":79},{"name":98,"role":73,"phone":39,"phoneExt":39,"email":39},"Casey L. O'Connell, MD",{"facility":100,"status":83,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":101,"geoPoint":103,"contacts":104},"USC \u002F Norris Comprehensive Cancer Center",{"type":90,"coordinates":102},[92,93],{"lat":93,"lon":92},[105,106],{"name":76,"role":77,"phone":78,"phoneExt":39,"email":79},{"name":98,"role":73,"phone":39,"phoneExt":39,"email":39},{"type":108,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[110],{"name":111,"class":112},"National Cancer Institute (NCI)","NIH","100520970","phase-2-curcumin-to-improve-inflammation-and-symptoms-in-patients-with-clonal-cytopenia-of-undetermined-significance-low-risk-myelodysplastic-syndrome-and-myeloproliferative-neoplasms-100520970",false,"NCT06063486","Curcumin to Improve Inflammation and Symptoms in Patients With Clonal Cytopenia of Undetermined Significance, Low Risk Myelodysplastic Syndrome, and Myeloproliferative Neoplasms","A Phase 2, Double-blind, Randomized Study to Compare the Effect of Curcumin Versus Placebo on Inflammatory Cytokines, Symptoms and Disease Parameters in Clonal Cytopenia of Undetermined Significance (CCUS), Low-Risk Myelodysplastic Syndrome (LR-MDS), and Myeloproliferative Neoplasms (MPNs)","Inclusion Criteria:\n\n* Age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2\n* Ability to understand and willingness to sign a written informed consent\n* Diagnosis of polycythemia vera (PV), essential thrombocytosis (ET) or myelofibrosis (MF) per World Health Organization (WHO) 2016 diagnostic criteria\n\n  * Presence of at least one symptom measurable using the MPN-\u002FSymptom Assessment Form (SAF) with a severity greater than 3\n  * MPN patients determined to have stable disease undergoing surveillance and unlikely to require initiation of new cytoreductive therapy (i.e., hydroxyurea, ruxotinib, interferon within the study period); patients on a stable dose of hydroxyurea for at least 6 months who meet the other inclusion\u002Fexclusion criteria may be included\n* A diagnosis of CCUS or LR-MDS\n\n  * CCUS defined as persistent cytopenia for \\> 6 months (hemoglobin \\[Hgb\\] \\\u003C 11.3 g\u002FdL \\[7 mmol\u002FL\\] in women and Hgb \\\u003C 12.9 g\u002FdL \\[8 mmol\u002FL\\] in men, platelet \\\u003C 150 x 10\\^9\u002FL or neutrophils \\\u003C 1.8 x 10\\^9\u002FL), normal cytogenetics, presence of detectable MDS associated mutations and bone marrow morphology non-diagnostic of MDS or any other malignancies\n  * LR-MDS as defined by WHO 2016 diagnosis criteria\n  * Minimum baseline symptom score of 25 in the fatigue section of the symptom questionnaire\n\nExclusion Criteria:\n\n* Patients with intake of curcumin as a dietary supplement, including multivitamin and unwillingness to quit more than 24 hours before study start\n* Patients with inability to understand and adhere to information given\n* Patients receiving active treatment for another malignancy except with hormonal therapy for a malignancy considered to be in remission or growth factors (erythropoietin, granulocyte colony-stimulating factor \\[G-CSF\\] and luspatercept)\n* Patients with intermediate or high-risk MDS\n* Patients must not be pregnant or nursing\n* Patients must not be on any oral or intravenous steroid or any other anti-inflammatories (ibuprofen \\> 200mg\u002Fweek or 400mg\u002Fmonth, naproxen of any dose, \\> 325mg aspirin daily, any herbal anti-inflammatory concoction of any dose)","ALL","18 Years",{"count":123,"type":124},30,"ESTIMATED","INTERVENTIONAL",[127],"PHASE2","This phase II trial evaluates how a curcumin supplement (C3 complex\u002FBioperine) changes the inflammatory response and symptomatology in patients with clonal cytopenia of undetermined significance (CCUS), low risk myelodysplastic syndrome (LR-MDS), and myeloproliferative neoplasms (MPN). Chronic inflammation drives disease development and contributes to symptoms experienced by patients with CCUS, LR-MDS, and MPN. Curcumin has been shown to have anti-inflammatory and anti-cancer properties and has been studied in various chronic illnesses and hematologic diseases.",[130,131,132,133,134],"Clonal Cytopenia of Undetermined Significance","Essential Thrombocythemia","Myelodysplastic Syndrome","Myelofibrosis","Polycythemia Vera","2026-03-24",{"date":137,"type":138},"2026-03-27","ACTUAL",{"date":140,"type":138},"2024-03-01",{"date":142,"type":124},"2027-03-01",{"name":5,"class":6},2]