[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539045":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":38,"centralContacts":43,"locations":48,"responsibleParty":76,"collaborators":78,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":27,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":27,"enrollmentInfo":92,"targetDuration":27,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":103,"overallStatus":64,"whyStopped":27,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Fred Hutchinson Cancer Center","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: High-Intensity Exercise (EX)","EXPERIMENTAL","10 participants will complete:\n\n* In-office baseline visit.\n* Virtual exercise sessions 3x weekly.\n* Post-intervention in-office visit.",[13],"Behavioral: Exercise Program",{"label":15,"type":10,"description":16,"interventionNames":17},"Group B: High-Fiber Diet (DT)","10 participants will complete:\n\n* In-office baseline visit.\n* 1x weekly appointment with research staff to review to review diet adherence.\n* Post-intervention in-office visit.",[18],"Behavioral: Diet Program",{"label":20,"type":10,"description":21,"interventionNames":22},"Group C: Combined High-Intensity Exercise and High-fiber Diet (COMB)","10 participants will complete:\n\n* In-office baseline visit.\n* Virtual exercise sessions 3x weekly.\n* 1x weekly appointment with research staff via Zoom platform to review to review diet adherence. Diet appointment may be combined with exercise session appointment.\n* Post-intervention in-office visit.",[13,18],{"label":24,"type":25,"description":26,"interventionNames":27},"Group D: Attention Control (AC)","NO_INTERVENTION","10 participants will complete:\n\n* In-office baseline visit.\n* Participants will receive a general healthy lifestyle guidebook.\n* Pot-intervention in-office visit.",null,[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":27},"BEHAVIORAL","Exercise Program","A high-intensity interval training, aerobic exercise program virtually supervised, home-based, and appointment-based program under direct one-on-one supervision by a trained oncology exercise specialist. Sessions will be conducted via the Zoom platform. Participants will be provided with home stationary bike, heart rate monitor, blood pressure monitor. For participants who do not have a smart device, a Wi-Fi enabled tablet will be provided.",[9,20],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":27},"Diet Program","A virtual dietary consultation program supervised by trained research staff. Appointments will be conducted via the Zoom platform. Participants will receive an education handout at the baseline visit.",[15,20],[39],{"name":40,"affiliation":41,"role":42},"Dong-Woo Kang, PhD","Fred Hutch\u002FUniversity of Washington Cancer Consortium","PRINCIPAL_INVESTIGATOR",[44],{"name":40,"role":45,"phone":46,"phoneExt":27,"email":47},"CONTACT","206-667-5188","dkang@fredhutch.org",[49,63],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":27},"Dana-Farber Cancer Institute","ACTIVE_NOT_RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-71.05977,42.35843,{"lat":61,"lon":60},{"facility":41,"status":64,"city":65,"state":66,"zip":67,"country":55,"countryCode":56,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"RECRUITING","Seattle","Washington","98109",{"type":58,"coordinates":69},[70,71],-122.33207,47.60621,{"lat":71,"lon":70},[74,75],{"name":40,"role":45,"phone":46,"phoneExt":27,"email":47},{"name":40,"role":42,"phone":27,"phoneExt":27,"email":27},{"type":77,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[79,81],{"name":80,"class":6},"World Cancer Research Fund International",{"name":82,"class":6},"American Association for Cancer Research","100539045","high-intensity-exercise-and-high-fiber-diet-for-immunotherapy-outcomes-in-melanoma-patients-the-duo-trial-100539045",false,"NCT06298734","High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial","Modulating Immune-Microbiome Axis Through High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically diagnosed with melanoma.\n* Having been or newly receiving immunotherapy for at least one month.\n* Having a plan to continue immunotherapy for at least 8 weeks at the time of recruitment.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2, indicating the ability to fulfill physical fitness and function assessments.\n* Ability to understand and willingness to provide informed consent.\n\nExclusion Criteria:\n\n* Participating in ≥ 150 minutes of moderate-to-vigorous aerobic exercise per week over the past month.\n* Consuming ≥ 30 grams\u002Fday of dietary fiber over the past month.\n* Having chronic medical conditions that are clinically unstable or uncontrolled with medications, deemed high-risk for exercise. These include but are not limited to unstable cardiac diseases, uncontrolled diabetes, and bone metastases with imminent risk of fracture.\n* Having a high risk for noncompliance with study procedures. This will be determined by the study team based on the history of missed oncology appointments (i.e., ≥3 no-shows in 6 months) and poor responsiveness during recruitment (i.e., ≥3 unreturned contacts).\n* Patients who are non-English speaking and cannot complete the participant surveys.","ALL","18 Years",{"count":93,"type":94},40,"ESTIMATED","INTERVENTIONAL",[97],"NA","The purpose of this study is to determine whether high-intensity exercise and high-fiber diet are feasible and improve various health outcomes among participants with advanced melanoma receiving immunotherapy.\n\nThe names of the groups in this research study are:\n\n* High-Intensity Exercise (EX)\n* High-fiber Diet (DT)\n* Combined High-Intensity Exercise and High-Fiber Diet (COMB)\n* Attention Control (AC)",[100,101,102],"Melanoma (Skin)","Skin Cancer","Advanced Melanoma",[104,101,102],"Melanoma","2026-06-15",{"date":107,"type":108},"2026-06-17","ACTUAL",{"date":110,"type":108},"2024-07-01",{"date":112,"type":94},"2027-03-31",{"name":5,"class":6},2]