[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510031":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":41,"centralContacts":45,"locations":51,"responsibleParty":69,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":28,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":28,"enrollmentInfo":85,"targetDuration":28,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":28,"overallStatus":95,"whyStopped":28,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Endeavor Health","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Carboplatin and paclitaxel with standard diet","ACTIVE_COMPARATOR","Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6-10 cycles in the absence of disease progression or unacceptable toxicity. A standard diet is consumed throughout each cycle of therapy.",[13,14,15],"Drug: Carboplatin","Drug: Paclitaxel","Dietary Supplement: Standard diet",{"label":17,"type":18,"description":19,"interventionNames":20},"Carboplatin and paclitaxel with fasting mimicking diet (FMD)","EXPERIMENTAL","Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of each cycle. Treatment repeats every 3 weeks for 6-10 cycles in the absence of disease progression or unacceptable toxicity. A fasting mimicking diet (FMD) is consumed beginning 3 days prior to chemotherapy and on the day of chemotherapy (days -2, -1, 0 and 1 of each cycle).",[21,13,14],"Dietary Supplement: Fasting Mimicking Diet (Xentigen by L'Nutra)",[23,29,34,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DIETARY_SUPPLEMENT","Fasting Mimicking Diet (Xentigen by L'Nutra)","L-Nutra Xentigen is a product which will provide all the food to be consumed by subjects during 3 days prior to chemotherapy and for 24 hours after chemotherapy. Xentigen is a plant-based diet program designed to attain fasting-like effects while providing both macro- and micronutrients to minimize the burden of fasting and adverse effects. The FMD consists of 100% ingredients that are generally regarded as safe (GRAS) and comprises proprietary vegetable-based soups and broths, energy bars, energy drinks, cracker snacks, herbal teas, and supplements. The FMD consists of a 4-day regimen that provides approximately 1100 kilocalories for the first day and approximately 500 kilocalories per day for the second to the fourth day. Subsequently, a day 5 of transition diet (approximately 800 kilocalories) is provided to avoid the refeeding syndrome.",[17],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"DRUG","Carboplatin","Given IV",[17,9],{"type":30,"name":35,"description":32,"armGroupLabels":36,"otherNames":28},"Paclitaxel",[17,9],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Standard diet","Normal diet",[9],[42],{"name":43,"affiliation":5,"role":44},"Mary T Jenkins Vogel, MD","PRINCIPAL_INVESTIGATOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":28,"email":50},"Michele Britto, RN","CONTACT","(847) 570-2109","mbritto@northshore.org",[52],{"facility":53,"status":28,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"NorthShore University HealthSystem","Evanston","Illinois","60201","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-87.69006,42.04114,{"lat":63,"lon":62},[66,68],{"name":47,"role":48,"phone":67,"phoneExt":28,"email":50},"847-570-2109",{"name":43,"role":44,"phone":28,"phoneExt":28,"email":28},{"type":44,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Tilley Jenkins-Vogel","Principal Investigator",[73],{"name":74,"class":75},"L-Nutra Inc","INDUSTRY","100510031","fasting-mimicking-diet-fmd-in-conjunction-with-chemotherapy-in-advanced-ovarian-cancer-100510031",false,"NCT05921149","Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer","A Randomized Controlled Study of a Fasting Mimicking Diet (FMD) in Conjunction With Combination Carboplatin and Paclitaxel in the Treatment of Patients With Advanced or Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. All patients with advanced ovarian, fallopian tube and primary peritoneal carcinomas deemed appropriate candidates for neoadjuvant chemotherapy and patients with recurrent, platinum-sensitive disease (as defined by an interval of at least 6 months following completion of last platinum-based chemotherapy prior to disease relapse or progression)\n3. ECOG Performance Status of 0, 1 or 2.\n4. Adequate bone marrow reserve (absolute neutrophil count (ANC) ≥1.5 x 109\u002FL and platelet count ≥100 x 109\u002FL).\n5. Adequate renal function defined as creatinine ≤1.5 x laboratory upper limit of normal (ULN).\n6. Adequate hepatic function defined as:\n\n   Bilirubin ≤1.5 x ULN ALT and AST ≤3 x ULN\n7. BMI ≥19 kg\u002Fm2\n\nExclusion Criteria:\n\n1. Patients with malnutrition and\u002F or BMI \\\u003C19\n2. Patients with active eating disorders (as identified by history of pre-enrollment nutrition screen)\n3. Diabetes mellitus requiring medication management (both insulin and non-insulin requiring). Patients with diabetes mellitus controlled by diet alone (i.e. patients not requiring anti-glycemic medications) are NOT excluded and are eligible for participation.\n4. Allergy to component of fasting mimicking diet (FMD)\n5. Patients with recurrent ovarian, fallopian tube and primary peritoneal carcinomas with relapse within 6 months of completion of last platinum-based chemotherapy regimen (i.e. patients with platinum-resistant disease)","FEMALE","18 Years",{"count":86,"type":87},170,"ESTIMATED","INTERVENTIONAL",[90],"NA","Rates of grade 3-4 toxicity with carboplatin and paclitaxel chemotherapy range 26-84%. Interventions to reduce toxicity are needed.\n\nShort term fasting protects against toxic effects of chemotherapy without decreasing efficacy. In a prospective clinical trial of breast cancer patients randomized to FMD or regular diet during chemotherapy, less antiemetic was required in the FMD group; radiographic and pathologic responses were better in this group.\n\nThis trial tests whether platinum-taxane chemotherapy combined with a FMD in advanced and recurrent ovarian, fallopian tube and primary peritoneal cancer patients is associated with decreased toxicity and\u002F or improved tumor response to therapy.",[93,94],"Ovarian Cancer","Chemotherapeutic Toxicity","NOT_YET_RECRUITING","2024-05-05",{"date":98,"type":99},"2024-05-07","ACTUAL",{"date":101,"type":87},"2024-05-25",{"date":103,"type":87},"2031-06-01",{"name":5,"class":6},1]