[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100195427":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":18,"locations":24,"responsibleParty":56,"collaborators":18,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":80,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":18,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Phytogen Medical Foods S.L.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"single-arm","EXPERIMENTAL","Two capsules in the morning, one at night, every day for a month, taken with a glass of water.",[13],"Dietary Supplement: PhytoMed™",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":18},"DIETARY_SUPPLEMENT","PhytoMed™",null,[9],[21],{"name":22,"affiliation":5,"role":23},"Guillermo Muñoz","STUDY_CHAIR",[25,36,41,46,51],{"facility":26,"status":18,"city":27,"state":27,"zip":18,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":18},"Hospital Quirón","Madrid","Spain","ES",{"type":31,"coordinates":32},"Point",[33,34],-3.70256,40.4165,{"lat":34,"lon":33},{"facility":37,"status":18,"city":27,"state":27,"zip":18,"country":28,"countryCode":29,"cosmosGeoPoint":38,"geoPoint":40,"contacts":18},"Hospital Universitario La Paz",{"type":31,"coordinates":39},[33,34],{"lat":34,"lon":33},{"facility":42,"status":18,"city":27,"state":27,"zip":18,"country":28,"countryCode":29,"cosmosGeoPoint":43,"geoPoint":45,"contacts":18},"Hospital Universitario Puerta de Hierro",{"type":31,"coordinates":44},[33,34],{"lat":34,"lon":33},{"facility":47,"status":18,"city":27,"state":27,"zip":18,"country":28,"countryCode":29,"cosmosGeoPoint":48,"geoPoint":50,"contacts":18},"Hospital Universitario Ramón y Cajal",{"type":31,"coordinates":49},[33,34],{"lat":34,"lon":33},{"facility":52,"status":18,"city":27,"state":27,"zip":18,"country":28,"countryCode":29,"cosmosGeoPoint":53,"geoPoint":55,"contacts":18},"MD Anderson Cancer Center",{"type":31,"coordinates":54},[33,34],{"lat":34,"lon":33},{"type":57,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100195427","changes-in-biomarkers-of-cancer-in-women-with-breast-cancer-and-without-evidence-of-disease-who-were-given-phytomed-100195427",false,"NCT01819948","Changes in Biomarkers of Cancer in Women With Breast Cancer and Without Evidence of Disease Who Were Given PhytoMed™","Pilot Clinical Trial to Assess Changes in Biomarkers of Cancer Related to Inflammation in Women With Stage 0-IIIA Breast Cancer and Without Evidence of Disease Who Were Given the PhytoMed™ Complement.","Inclusion Criteria:\n\n* Women with histologically confirmed AJCC Stage 0-IIIA breast cancer which has been completely surgically resected.\n* No evidence of disease as determined by their physician.\n* ER+ and\u002For PR+ tumour.\n* Receiving an aromatase inhibitor (letrozole, anastrazole, exemestane) or tamoxifen at a stable dose for at least 3 months at trial entry.\n* Post-menopausal women, defined as: (1) above 50 years of age who have not menstruated during the preceding 12 months or who have follicle-stimulating hormone levels (FSH) \\> 40 IU\u002FL, (2) those under 50 years of age who have FSH hormone levels \\>40 IU\u002FL, or (3) those who have undergone a bilateral oophorectomy.\n* CRP ≥3.9 mg\u002FL measured as the mean of two consecutive weekly tests.\n* Aged 18 years or older\n* ECOG performance status 0-1\n* Between 2 and 5 years from their initial surgery for breast cancer.\n* Life expectancy of at least 6 months\n* At least 6 months since last chemotherapy\n* Laboratory tests performed within 14 days of trial starting:\n\n  1. Granulocytes ≥ 1,500\u002FµL;\n  2. Platelets ≥ 100,000\u002FµL;\n  3. Haemoglobin ≥ 12.0 g\u002FdL;\n  4. Total bilirubin equal to or below upper limit of normal (ULN);\n  5. AST and ALT equal to or below ULN;\n  6. Alkaline phosphatase equal to or below ULN;\n  7. Serum creatinine equal to or below ULN;\n* Able to provide informed consent to receive the trial treatment, to provide biological specimens, self-administer oral medica-tion unsupervised for a prolonged period of time, and to complete a medication diary.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Who have had a malignancy (other than breast cancer) which required radiotherapy or systemic treatment within the past 5 years.\n* Known cardiac disease (arrhythmias, myocardial infarction, bundle branch block, ischemic heart disease, uncontrolled hypertension)\n* Known autoimmune disease or inflammatory disorder\n* Any condition requiring the use of systemic corticosteroids or any other immunosuppressive agents (e.g. cyclosporin, tacrolimus, azathioprine).\n* Women with known immunodeficiency (such as HIV).\n* Patients with infection by septicaemia, infection, acute hepatitis, or other uncontrolled severe medical condition\n* Routine use of aspirin \\>81 mg\u002Fd or NSAIDs (\\> 400 mg po 4 times\u002Fday of ibuprofen or naproxen \\> 500 mg\u002Fd) or any use of celecoxib or similar COX-2 inhibitors;\n* Subjects are asked not to take dietary supplements, olives or olive oil for 1 month prior to trial enrolment and during the trial.\n* Who are taking bisphosphonates","FEMALE","18 Years",{"count":68,"type":69},46,"ACTUAL","INTERVENTIONAL",[72],"NA","The purpose of this study is to determine whether the administration of the PhytoMed™ complement reduces CRP in women with histologically confirmed AJCC Stage 0-IIIA breast cancer which has been completely surgically resected and without evidence of disease as determined by their physician",[75],"Breast Cancer",[77,78,79],"Breast cancer","Stage 0-IIIA","No evidence of disease","COMPLETED","2016-02-24",{"date":83,"type":84},"2016-02-25","ESTIMATED",{"date":86,"type":18},"2012-06",{"name":5,"class":6},5]