[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653735":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":37,"studyPopulation":30,"armGroups":38,"interventions":57,"overallOfficials":110,"centralContacts":30,"locations":114,"responsibleParty":146,"collaborators":148,"id":152,"slug":153,"hasResults":154,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":30,"eligibilityCriteria":158,"healthyVolunteers":154,"sex":159,"minAge":160,"maxAge":161,"enrollmentInfo":162,"targetDuration":30,"studyType":165,"phases":166,"briefSummary":168,"conditions":169,"keywords":30,"overallStatus":116,"whyStopped":30,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"fullName":5,"class":6},"City of Hope Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":30},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Colon tissue molecular profiles - Whole genome sequencing","Whole genome sequencing will be measured in colonic mucosa. Will be compared from baseline to 6 months post-intervention using the paired Wilcoxon signed rank test and McNemar's test for numeric and categorical features, respectively.","From baseline up to completion of follow-up colonoscopy\u002Fflex sigmoidoscopy (up to 3 months)",{"measure":14,"description":15,"timeFrame":12},"Colon tissue molecular profiles - Single-cell ribonucleic acid sequencing","Single-cell ribonucleic acid sequencing will be measured in colonic mucosa. Will be compared from baseline to 6 months post-intervention using the paired Wilcoxon signed rank test and McNemar's test for numeric and categorical features, respectively.",{"measure":17,"description":18,"timeFrame":12},"Colon tissue molecular profiles - Associated molecular assays","Associated molecular assays will be measured in colonic mucosa. Will be compared from baseline to 6 months post-intervention using the paired Wilcoxon signed rank test and McNemar's test for numeric and categorical features, respectively.",[20,24,27],{"measure":21,"description":22,"timeFrame":23},"Blood-based biomarkers - blood immune-inflammatory profile","Blood-based biomarkers - blood immune-inflammatory profile will be measured. Will be compared from baseline to 6 months post-intervention using the paired Wilcoxon signed rank test and McNemar's test for numeric and categorical features, respectively.","From baseline to 6 months post-intervention (up to 6 months)",{"measure":25,"description":26,"timeFrame":23},"Blood-based biomarkers - ambient deoxyribonucleic acid damage","Blood-based biomarkers - ambient deoxyribonucleic acid damage in circulating peripheral blood mononuclear cells will be measured. Will be compared from baseline to 6 months post-intervention using the paired Wilcoxon signed rank test and McNemar's test for numeric and categorical features, respectively.",{"measure":28,"description":29,"timeFrame":23},"Blood-based biomarkers - accumulation of colorectal cancer associated metabolites including deoxycholic bile acid","Blood-based biomarkers - accumulation of colorectal cancer associated metabolites including deoxycholic bile acid will be measured. Will be compared from baseline to 6 months post-intervention using the paired Wilcoxon signed rank test and McNemar's test for numeric and categorical features, respectively.",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"NON_RANDOMIZED","SEQUENTIAL","SUPPORTIVE_CARE",{"masking":36,"maskingDescription":30,"whoMasked":30},"NONE","PRIMARY OBJECTIVE:\n\nI. Determine the effects of exercise on mitigating molecular features in collected normal mucosa sample and any polyps identified.\n\nSECONDARY OBJECTIVES:\n\nI. Study longitudinal changes in predictors of colon cancer risk. II. Evaluate accrual and retention rates, as well as exercise compliance and safety.\n\nEXPLORATORY OBJECTIVE:\n\nI. Bank tissue from standard of care colonoscopies\u002Fflex sigmoidoscopies for exploratory biological analyses (e.g., immune cell infiltration, mutational signature analysis).\n\nOUTLINE:\n\nSTAGE 1: Patients undergo standard of care (SOC) colonoscopy\u002Fflex sigmoidoscopy with tissue biopsy, have their Apple Health physical activity data collected and analyzed, and complete a survey. Patients determined to have low physical activity over the previous 12 months may proceed to Stage 2.\n\nSTAGE 2: Patients participate in individualized walking sessions over 10-70 minutes each, 5 times per week (225 minutes total per week), for 6 months. Patients also undergo collection of a blood sample on study and undergo SOC colonoscopy\u002Fflex sigmoidoscopy with tissue biopsy during follow-up.\n\nAfter completion of study intervention, patients are followed up within 2 weeks, or up to 3 months, for completion of follow-up SOC colonoscopy\u002Fflex sigmoidoscopy.",[39,48],{"label":40,"type":6,"description":41,"interventionNames":42},"Stage 1 (coloscopy\u002Fsigmoidoscopy, biopsy, health data)","Patients undergo SOC colonoscopy\u002Fflex sigmoidoscopy with tissue biopsy, have their Apple Health physical activity data collected and analyzed, and complete a survey. Patients determined to have low physical activity over the previous 12 months may proceed to Stage 2.",[43,44,45,46,47],"Procedure: Biopsy Procedure","Procedure: Colonoscopy","Other: Data Collection","Procedure: Sigmoidoscopy","Other: Survey Administration",{"label":49,"type":50,"description":51,"interventionNames":52},"Stage 2 (individualized walking)","EXPERIMENTAL","Patients participate in individualized walking sessions over 10-70 minutes each, 5 times per week (225 minutes total per week), for 6 months. Patients also undergo collection of a blood sample on study and undergo SOC colonoscopy\u002Fflex sigmoidoscopy with tissue biopsy during follow-up.",[53,43,54,44,55,56,46],"Other: Aerobic Exercise","Procedure: Biospecimen Collection","Other: Physical Performance Testing","Other: Questionnaire Administration",[58,64,73,82,86,90,97,100,106],{"type":6,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Aerobic Exercise","Participate in individualized walking sessions",[49],[63],"Aerobic Activity",{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"PROCEDURE","Biopsy Procedure","Undergo biopsy",[40,49],[70,71,72],"Biopsy","BIOPSY_TYPE","Bx",{"type":65,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"Biospecimen Collection","Undergo collection of blood sample",[49],[78,79,80,81],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":65,"name":83,"description":84,"armGroupLabels":85,"otherNames":30},"Colonoscopy","Undergo SOC colonoscopy",[40,49],{"type":6,"name":87,"description":88,"armGroupLabels":89,"otherNames":30},"Data Collection","Undergo collection of Apple Health data",[40],{"type":6,"name":91,"description":92,"armGroupLabels":93,"otherNames":94},"Physical Performance Testing","Ancillary studies",[49],[95,96],"Physical Fitness Testing","Physical Function Testing",{"type":6,"name":98,"description":92,"armGroupLabels":99,"otherNames":30},"Questionnaire Administration",[49],{"type":65,"name":101,"description":102,"armGroupLabels":103,"otherNames":104},"Sigmoidoscopy","Undergo SOC flex sigmoidoscopy",[40,49],[105],"Proctosigmoidoscopy",{"type":6,"name":107,"description":108,"armGroupLabels":109,"otherNames":30},"Survey Administration","Complete survey",[40],[111],{"name":112,"affiliation":5,"role":113},"Gregory Idos","PRINCIPAL_INVESTIGATOR",[115,134],{"facility":5,"status":116,"city":117,"state":118,"zip":119,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":127,"contacts":128},"RECRUITING","Duarte","California","91010","United States","US",{"type":123,"coordinates":124},"Point",[125,126],-117.97729,34.13945,{"lat":126,"lon":125},[129,133],{"name":112,"role":130,"phone":131,"phoneExt":30,"email":132},"CONTACT","626-228-4207","gidos@coh.org",{"name":112,"role":113,"phone":30,"phoneExt":30,"email":30},{"facility":135,"status":116,"city":136,"state":118,"zip":137,"country":120,"countryCode":121,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"City of Hope at Irvine Lennar","Irvine","92618",{"type":123,"coordinates":139},[140,141],-117.82311,33.66946,{"lat":141,"lon":140},[144,145],{"name":112,"role":130,"phone":131,"phoneExt":30,"email":132},{"name":112,"role":113,"phone":30,"phoneExt":30,"email":30},{"type":147,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[149],{"name":150,"class":151},"National Cancer Institute (NCI)","NIH","100653735","testing-the-effects-of-exercise-on-colorectal-cancer-development-after-treatment-with-pelvic-radiation-therapy-for-prostate-cancer-100653735",false,"NCT07790718","Testing the Effects of Exercise on Colorectal Cancer Development After Treatment With Pelvic Radiation Therapy for Prostate Cancer","The Effects of Exercise on Colorectal Cancer Promotion Following Pelvic Radiotherapy for Prostate Cancer","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: 40-80 years\n* Body mass index (BMI): \\> 25 kg\u002Fm\\^2\n* Has Apple Health application (app) on personal device with valid iOS operating software (i.e., iOS 15.0 or higher)\n* Has a registered MyChart\u002FMyCityofHope account (or be willing to register for one) and the app downloaded onto personal device\n* Ability to read and understand English to review MyChart\u002FMyCityofHope on-screen instructions to sync and share Apple Health data, and for safety during exercise testing\n* Previously diagnosed with localized prostate cancer\n* Completed pelvic radiotherapy 12-20 months ago\n* Presence of abnormalities (e.g., polyps, lesions) in the colon\n* Assessed for exercise participation as per pre-screening clearance via the Physical Activity Readiness Questionnaire (PAR-Q+) (stage 2 only)\n* Low physical activity, defined by \\\u003C 5,000 steps\u002Fday over the last 12 months as per Apple Health data (stage 2 only)\n\nExclusion Criteria:\n\n* Enrollment in any other program (e.g., weight loss program) that may alter the impact of exercise on outcomes\n* Presence of any other concurrent, actively treated malignancy\n* Distant metastatic malignancy of any kind\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","MALE","40 Years","80 Years",{"count":163,"type":164},30,"ESTIMATED","INTERVENTIONAL",[167],"NA","This clinical trial evaluates the effects of exercise therapy on signs of colorectal cancer in colon tissue and blood in people who completed pelvic radiation therapy for prostate cancer. People who get radiation in the pelvic area have a higher chance of developing colon cancer years later. This is because radiation can cause new mutations and inflammation. Research shows that exercise lowers colon cancer risk by about 30%. The results of this trial may help researchers better understand how exercise affects the development of colorectal cancer in patients who were treated with pelvic radiation therapy for prostate cancer.",[170,171,172,173,174,175],"Colon Polyp","Colorectal Carcinoma","Localized Prostate Carcinoma","Stage I Prostate Cancer AJCC v8","Stage II Prostate Cancer AJCC v8","Stage III Prostate Cancer AJCC v8","2026-08-26",{"date":178,"type":179},"2026-08-28","ACTUAL",{"date":181,"type":164},"2026-12-16",{"date":183,"type":164},"2027-06-12",{"name":5,"class":6},2]