[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100353326":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":54,"centralContacts":58,"locations":63,"responsibleParty":81,"collaborators":44,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":44,"eligibilityCriteria":88,"healthyVolunteers":85,"sex":89,"minAge":90,"maxAge":44,"enrollmentInfo":91,"targetDuration":44,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":44,"overallStatus":65,"whyStopped":44,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Roswell Park Cancer Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Supportive care (diet, exercise, education)","EXPERIMENTAL","Patients receive an individualized diet plan for 6 months. Patients complete an individualized home-based exercise program aerobic and resistance exercise over 10-30 minutes per day, at minimum 3 days per week for 6 months, and a progressive resistance exercise program including an individually tailored prescription targeting the chest, shoulders, arms, and leg musculature for 1-4 sets of 10-15 repetitions, 5 days per week over 6 months. Patients also attend monthly educational meetings for 6 months.",[13,14,15,16,17],"Dietary Supplement: Dietary Intervention","Other: Educational Intervention","Behavioral: Exercise Intervention","Other: Quality-of-Life Assessment","Other: Survey Administration",[19,30,39,45,51],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIETARY_SUPPLEMENT","Dietary Intervention","Receive diet plan",[9],[25,26,27,28,29],"Dietary Modification","intervention, dietary","Nutrition Intervention","Nutrition Interventions","Nutritional Interventions",{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Educational Intervention","Attend educational meeting",[9],[35,36,37,38],"Education for Intervention","Intervention by Education","Intervention through Education","Intervention, Educational",{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"BEHAVIORAL","Exercise Intervention","Complete exercise program",[9],null,{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Quality-of-Life Assessment","Ancillary studies",[9],[50],"Quality of Life Assessment",{"type":6,"name":52,"description":47,"armGroupLabels":53,"otherNames":44},"Survey Administration",[9],[55],{"name":56,"affiliation":5,"role":57},"Ellis Levine, MD","PRINCIPAL_INVESTIGATOR",[59],{"name":56,"role":60,"phone":61,"phoneExt":44,"email":62},"CONTACT","716-845-3159","Ellis.Levine@Roswellpark.org",[64],{"facility":5,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"RECRUITING","Buffalo","New York","14263","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-78.87837,42.88645,{"lat":75,"lon":74},[78,80],{"name":56,"role":60,"phone":61,"phoneExt":44,"email":79},"Ellis.Levine@roswellpark.org",{"name":56,"role":57,"phone":44,"phoneExt":44,"email":44},{"type":82,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100353326","nutrition-and-exercise-interventions-for-androgen-deprivation-therapy-induced-obese-frailty-in-elderly-and-non-elderly-survivors-of-advanced-prostate-cancer-100353326",false,"NCT03880422","Nutrition and Exercise Interventions for Androgen Deprivation Therapy-Induced Obese Frailty in Elderly and Non-Elderly Survivors of Advanced Prostate Cancer","Inclusion Criteria:\n\n* Biopsy-confirmed prostate adenocarcinoma of any stage\u002Fgrade\n* Prescribed or already receiving continuous ADT for \\\u003C 5 years\n* Hemoglobin \\> 11 g\u002FdL\n* Creatinine \\\u003C 1.5 x upper limit of normal (ULN), AST or ALT \\\u003C2 x ULN within 6 months prior to enrollment\n* Liver function tests \\\u003C 2 x ULN\n* Able to walk unassisted at least 100 meters (200 steps) or ECOG \\\u003C= 1\n* No contraindications to any aspect of participation, including aerobic exercise\n* Participant must be able to read, write, and understand the English language and be able to provide written consent\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Known clinically significant severe chronic obstructive pulmonary disease (COPD), ischemic heart disease, congestive heart failure, and\u002For significant cardiac arrhythmias\n* Limiting orthopedic, musculoskeletal or psychological conditions (clinician discretion)\n* Overall medical frailty (clinician discretion)\n* Any condition contraindicating additional blood collection beyond standard of care\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study intervention","MALE","18 Years",{"count":92,"type":93},50,"ESTIMATED","INTERVENTIONAL",[96],"NA","This trial studies how well nutrition and exercise interventions work in reducing androgen deprivation therapy-induced obese frailty in prostate cancer survivors. Individualized nutrition and exercise advice for prostate cancer patients on androgen deprivation therapy may help to reduce obese frailty and change the levels of myokines in blood.",[99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118],"Cancer Survivor","Obesity","Overweight","Prostate Adenocarcinoma","Stage A Prostate Cancer","Stage B Prostate Cancer","Stage C Prostate Cancer","Stage D Prostate Cancer","Stage I Prostate Cancer","Stage II Prostate Cancer","Stage IIA Prostate Cancer","Stage IIB Prostate Cancer","Stage IIC Prostate Cancer","Stage III Prostate Cancer","Stage IIIA Prostate Cancer","Stage IIIB Prostate Cancer","Stage IIIC Prostate Cancer","Stage IV Prostate Cancer","Stage IVA Prostate Cancer","Stage IVB Prostate Cancer","2026-05-01",{"date":121,"type":122},"2026-05-07","ACTUAL",{"date":124,"type":122},"2019-05-02",{"date":126,"type":93},"2029-05-02",{"name":5,"class":6},1]