[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497770":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":24,"responsibleParty":60,"collaborators":62,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":18,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":18,"overallStatus":26,"whyStopped":18,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Yale University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Exercise and medical nutrition","EXPERIMENTAL","Over the intervention period (18 weeks on average - dependent on length of chemotherapy) women in the intervention arm will receive weekly counseling sessions, the study dietitian and exercise trainer will each conduct weekly sessions to assist the participants in achieving the diet and exercise study goals.",[13],"Behavioral: Exercise and medical nutrition",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","Contact limited to study assessments.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","The study dietitian and exercise trainer will each conduct weekly counseling sessions via telephone or zoom throughout the course of chemotherapy (approximately 18 weeks) to assist the participants in achieving the diet and exercise study goals. Participants will be provided written informational material, exercise bands for strength training and a Fitbit to record activity.\n\nParticipant goals are to: 1) participate in 150 min\u002Fweek of moderate-intensity physical activity 2) participate in two weekly strength training sessions; 3) eat a combination of 5 or more servings of vegetables and\u002For fruits per day 4) consume 25 grams or more of fiber\u002Fday; 5) consume adequate amounts of protein to prevent muscle wasting (1.2g\u002Fkg body weight).",[9],[25,45],{"facility":5,"status":26,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"RECRUITING","New Haven","Connecticut","06511","United States","US",{"type":33,"coordinates":34},"Point",[35,36],-72.92816,41.30815,{"lat":36,"lon":35},[39,44],{"name":40,"role":41,"phone":42,"phoneExt":18,"email":43},"Melinda Irwin, PhD","CONTACT","203-499-9405","melinda.irwin@yale.edu",{"name":18,"role":41,"phone":42,"phoneExt":18,"email":18},{"facility":46,"status":26,"city":47,"state":48,"zip":49,"country":30,"countryCode":31,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"University of Miami","Miami","Florida","33136",{"type":33,"coordinates":51},[52,53],-80.19366,25.77427,{"lat":53,"lon":52},[56],{"name":57,"role":41,"phone":58,"phoneExt":18,"email":59},"Tracy Crane, PhD","305-243-9832","Tecrane@miami.edu",{"type":61,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[63,64],{"name":46,"class":6},{"name":65,"class":66},"National Cancer Institute (NCI)","NIH","100497770","trial-of-exercise-and-lifestyle-for-women-with-ovarian-and-endometrial-cancer-100497770",false,"NCT05761561","Trial of Exercise and Lifestyle for Women With Ovarian and Endometrial Cancer","Trial of Exercise and Lifestyle (TEAL) for Women With Ovarian and Endometrial Cancer","TEAL","Inclusion Criteria:\n\n* have a diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, stage I-IV OR have a diagnosis of advanced or metastatic endometrial carcinoma (including carcinosarcoma) AND their treatment regimen includes carboplatin and taxane (or equivalent)\n* be scheduled to receive at least 6 cycles of neoadjuvant or adjuvant chemotherapy\n* be physically able to walk without a walking aid (e.g. cane or walker)\n* be able to complete forms, understand instructions and read intervention book in English or Spanish\n* agree to be randomly assigned to either group\n* have clearance from oncologist to participate\n* be ≥ 18 years of age\n\nExclusion Criteria:\n\n* having already completed a 2nd cycle of chemotherapy\n* already practicing dietary (\\>7 servings of fruits and vegetables per day) OR physical activity guidelines (≥150 min per week of moderate to vigorous exercise and resistance training two times per week) since diagnosis\n* pregnancy or intention to become pregnant\n* recent (past year) stroke\u002Fmyocardial infarction or congestive heart failure\u002Fejection fraction \\\u003C40%\n* presence of dementia or major psychiatric disease\n* in active treatment including target or biologic therapies for any other cancer (excluding hormone therapy treatments)\n* receiving external beam radiation","FEMALE","18 Years",{"count":78,"type":79},200,"ESTIMATED","INTERVENTIONAL",[82],"NA","An anticipated 200 women with newly diagnosed ovarian and endometrial cancer scheduled to receive chemotherapy (adjuvant chemotherapy after surgery or neoadjuvant chemotherapy before surgery) will be recruited from Smilow Cancer Hospital Network at Yale Cancer Center (YCC) and Sylvester Comprehensive Cancer Center (SCCC) at University of Miami.\n\nParticipants will be randomized to an exercise and medical nutrition intervention arm with weekly counseling sessions throughout chemotherapy, or a control arm.\n\nStudy assessments will be conducted at baseline, post-chemotherapy\u002Fend of intervention and at 1-year post diagnosis. Women who are prescribed neoadjuvant therapy will have additional assessments prior to surgery.\n\nData required to calculate the primary endpoint (relative dose intensity of chemotherapy) will be abstracted from the medical record directly following each chemotherapy session.",[85],"Ovarian Cancer","2026-06-17",{"date":88,"type":89},"2026-06-22","ACTUAL",{"date":91,"type":89},"2023-04-19",{"date":93,"type":79},"2027-12",{"name":5,"class":6},2]