[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07714018":3,"trial-entities:NCT07714018":109,"trial-summary:NCT07714018":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":44,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":88,"locations":91,"central_contacts":105,"overall_officials":106,"references":107,"see_also_links":108},"NCT07714018","I-4928826","Comparing Two Weight Loss Programs for the Prevention of Kidney Cancer Progression Among Patients With Small Renal Masses on Active Surveillance","Development and Analysis of Weight Loss Programs for Renal Cell Carcinoma Patients on Active Surveillance","NOT_YET_RECRUITING","2028-09-01","2026-07","2026-07-20","2026-09-01","Roswell Park Cancer Institute","OTHER",false,"This clinical trial compares two different weight-loss programs, daily continuous calorie energy reduction (CER) versus (vs.) 5:2 intermittent fasting (IF), in preventing progression of kidney (renal) cancer among patients with one or more small renal masses (SRM) undergoing active surveillance (AS). Kidney cancer patients tend to have changes in metabolism that may increase body weight, but weight-loss strategies that work for best for these patients are unknown. The CER program requires a set daily limit for calories. The IF program requires fasting for 2 days a week and normal eating for the remaining 5 days. Both will include self-monitoring with interventionist feedback. This trial may help researchers determine whether the IF program works better than the CER program in improving weight loss, physical health, and\u002For reducing the risk of kidney cancer progression among patients with small renal masses undergoing AS","PRIMARY OBJECTIVES:\n\nI. Adapt two evidence-based behavioral weight loss intervention programs (IF and CER) with a goal to cause weight loss in SRM patients on AS.\n\nII. Determine the feasibility of the two intervention programs (IF and CER).\n\nSECONDARY OBJECTIVE:\n\nI. Measure and explore preliminary effect sizes of IF vs. CER on body weight, diet, body composition, tumor growth, and rates of clinical progression and invasive treatment conversion",[19],"Renal Cell Carcinoma (RCC)",[],"INTERVENTIONAL","PREVENTION",[24],"NA",{"count":26,"type":27},20,"ESTIMATED",[29,34],{"type":14,"name":30,"description":31,"armGroupLabels":32},"Intermittent Fasting","The IF intervention will instruct participants how to fast safely, how to conduct a 5:2 fast, and encourage moderate physical activity. Self-monitoring with interventionist feedback will also be included",[33],"Arm II - IF Program",{"type":14,"name":35,"description":36,"armGroupLabels":37},"Continuous Energy Restriction (CER)","Lessons about lowering caloric intake each day and moderate physical activity with self-monitoring and interventionist feedback",[38],"Arm I - CER Program",[40],{"measure":41,"description":42,"timeFrame":43},"Participation Rate","This will assess the rate of eligible persons who enroll after invitation and the mean proportion of intervention components completed by arm and participant","At 6 months",[45,49,53,57],{"measure":46,"description":47,"timeFrame":48},"Change in tumor size","Will be assessed based on radiologic imaging. Within-group differences between baseline and 6 months will be examined using paired t-tests or Wilcoxon signed-rank tests for continuous variables, and McNemar's test for categorical variables.","At baseline and at 6 months",{"measure":50,"description":51,"timeFrame":52},"Rate of clinical progression","defined based on radiologic tumor size (\\> 4 cm), stage (\\> cT1a) and growth rate (\\> 5 mm\u002Fyear for \\\u003C 3 cm size; \\> 3 mm\u002Fyear for tumor size \\> 3 cm), in addition to biopsy histology (high grade or unclassified renal cell carcinoma histologic subtype) and patient symptomology (bleeding or paraneoplastic symptoms\u002Fsigns attributable to the tumor), as per the International Consultation for Urologic Disease guidelines","Up to 6 months",{"measure":54,"description":55,"timeFrame":56},"Recall of Dietary Intake","Participants will complete 3 recalls over the phone regarding dietary intake over a prior 24-hour period.","Baseline and 6 months",{"measure":58,"description":59,"timeFrame":60},"Change in Body composition","Will be measured using a body composition monitor, which uses bioelectrical impedance analysis to measure whole body and segmental body composition, including trunk fat..","Baseline and at 6 months","ALL","18 Years",null,{"inclusion":65,"exclusion":75,"raw_text":87},[66,67,68,69,70,71,72,73,74],"English speaking","SRM patient with biopsy-confirmed RCC who are initiating or already on AS for less than 5 years","Age 18 years or older","Body mass index (BMI) ≥ 25 kg\u002Fm\\^2","No medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component","No current medication that might affect weight loss","Not pregnant or lactating","No more than 5% body weight loss in the past 3 months","No bariatric surgery in the last 10 years",[76,77,78,79,80,81,82,83,84,85,86],"Non-English speaking","Less than 18 years old","BMI \\\u003C 25 kg\u002Fm\\^2","Medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component","Current medication that might affect weight loss","Pregnant or lactating","More than 105% body weight loss in the past 6 months","Bariatric surgery in the last 10 years","Medical conditions that might contraindicate short-term fasting periods","Unwilling or unable to follow protocol requirements","Received an investigational agent within 30 days prior to enrollment","Inclusion Criteria:\n\n* English speaking\n* SRM patient with biopsy-confirmed RCC who are initiating or already on AS for less than 5 years\n* Age 18 years or older\n* Body mass index (BMI) ≥ 25 kg\u002Fm\\^2\n* No medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component\n* No current medication that might affect weight loss\n* Not pregnant or lactating\n* No more than 5% body weight loss in the past 3 months\n* No bariatric surgery in the last 10 years\n\nExclusion Criteria:\n\n* Non-English speaking\n* Less than 18 years old\n* BMI \\\u003C 25 kg\u002Fm\\^2\n* Medical problems that might contraindicate participation in a behavioral weight reduction program containing an exercise component\n* Current medication that might affect weight loss\n* Pregnant or lactating\n* More than 105% body weight loss in the past 6 months\n* Bariatric surgery in the last 10 years\n* Medical conditions that might contraindicate short-term fasting periods\n* Unwilling or unable to follow protocol requirements\n* Received an investigational agent within 30 days prior to enrollment",[89,90],"ADULT","OLDER_ADULT",[92],{"facility":93,"city":94,"state":95,"zip":96,"country":97,"contacts":98,"geoPoint":102},"Roswell Park Comprehensive Cancer Center","Buffalo","New York","14263","United States",[99],{"name":100,"role":101},"Eric Kauffmann, MD","PRINCIPAL_INVESTIGATOR",{"lat":103,"lon":104},42.88645,-78.87837,[],[],[],[],{"nct_id":4,"conditions":110,"biomarkers":112},[111],"Renal Cell Carcinoma",[],{"nct_id":4,"found":114,"summary":115,"prompt_version":125},true,{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This interventional study compares two different weight loss programs, Intermittent Fasting and Continuous Energy Restriction, with about 20 participants.","completed","Weight Loss Programs for Kidney Cancer Prevention","This study is comparing two different weight loss programs, Intermittent Fasting (IF) and Continuous Energy Restriction (CER), for people with small kidney (renal) cancer masses who are under active surveillance (AS). The goal is to see if these programs can help prevent the cancer from getting worse. You could be eligible if you are an English-speaking adult (18+) with a biopsy-confirmed kidney cancer mass, are on active surveillance for less than 5 years, and have a BMI of 25 or higher. The study aims to see how many people participate in each program over 6 months. This study is currently recruiting about 20 participants.","The primary endpoint, participation rate, is measured at 6 months.",104,"You would participate in either the Intermittent Fasting or Continuous Energy Restriction program, which includes self-monitoring and feedback from an interventionist.","Not stated in the trial record.",[30,35],"v2"]