[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635114":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":41,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":26,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":87,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Dana-Farber Cancer Institute","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm AVE: Acupuncture + Virtual Exercise","EXPERIMENTAL","10 participants will complete:\n\n* In-clinic baseline visit\n* 3 exercise sessions with certified trainer per week\n* 1 in-clinic acupuncture session per week\n* One or two end of study in-clinic visits",[13,14],"Procedure: Acupuncture","Behavioral: Exercise",{"label":16,"type":17,"description":18,"interventionNames":19},"Arm VE: Virtual Exercise","ACTIVE_COMPARATOR","10 participants will complete:\n\n* In-clinic baseline visit\n* 3 exercise sessions with certified trainer per week\n* One or two end of study in-clinic visits",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Acupuncture","Acupuncture treatment with licensed acupuncturist.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BEHAVIORAL","Exercise","Virtually supervised, technology-based aerobic and resistance exercise program. Exercise bike and resistance bands will be provided to participants. Exercise sessions will be via HIPAA-compliant, teleconference platform Zoom.",[9,16],[33],{"name":34,"affiliation":5,"role":35},"Christina Dieli-Conwright, PhD, MPH","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","617-582-8321","ChristinaM_Dieli-Conwright@dfci.harvard.edu",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Dana Farber Cancer Institute","RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-71.05977,42.35843,{"lat":54,"lon":53},[57,59],{"name":34,"role":38,"phone":58,"phoneExt":26,"email":40},"617-632-3800",{"name":60,"role":35,"phone":26,"phoneExt":26,"email":26},"Christina Dieli-Conwright, PhD",{"type":35,"investigatorFullName":60,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Principal Investigator","100635114","acupuncture-and-exercise-for-ev-pembro-induced-peripheral-neuropathy-100635114",false,"NCT07548476","Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy","Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy (ACE)","ACE","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Diagnosed with pathologically proven urothelial cancer (UC)\n* Have received at least one cycle of EV-Pembro treatment with enrollment occurring after the 1st cycle and prior to the 4th cycle\n* Self-reported ability to walk for 6 minutes and\u002For 2 blocks\n* Deemed acceptable for exercise by their treating provider\n* Sedentary, currently engaging in less than or equal to 60 minutes of moderate or vigorous structured exercise\u002Fweek, as assessed by the Godin Leisure-Time Exercise Questionnaire\n* Willing to adhere to all study-related procedures, including randomization to either treatment group\n* Referrals to physical therapy are allowed during the study if necessary\n* Participants taking any of medications listed below must be on a stable regimen, with no changes in the past three months. Use of these medications may continue while on study.\n* Duloxetine, amitriptyline, nortriptyline, gabapentin, and pregabalin\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety of efficacy assessment of investigational regimen will be eligible.\n\nExclusion Criteria:\n\n* History of documented grade 2 or greater peripheral or motor neuropathy prior to EV-Pembro initiation; may confound assessment of the intervention's preventative effect\n* Patients with uncontrolled medical conditions that would preclude them from participating in moderate-to-vigorous intensity exercise in a virtual setting. Given the exercise environment is virtual, only patients with stable medical conditions should be enrolled to ensure their safety. Physical Activity Readiness Questionnaire (PARQ+) will be used during screening to facilitate conversations about present or historical medical conditions\n* Having continued grade 2 or higher adverse effects of their current treatment (EV-Pembro)\n* Receiving more than 10mg prednisone daily for any condition\n* History of bleeding diathesis (von Willebrand disease, hemophilia A\u002FB)\n* Known history of seizure disorder or taking antiepileptic drugs\n* Participate in more than 60 minutes of moderate or vigorous structured exercise\u002Fweek\n\nInvestigators will not include the following special populations:\n\n* Adults unable to consent\n* Individuals who are not yet adults (infants, children, teenagers \\\u003C 18 years)\n* Pregnant women\n* Prisoners","ALL","18 Years",{"count":74,"type":75},20,"ESTIMATED","INTERVENTIONAL",[78],"NA","The goal of this study is to evaluate the feasibility and preliminary efficacy of a combined acupuncture and exercise intervention for the management of chemotherapy-induced peripheral neuropathy (CIPN) in participants with bladder cancer receiving enfortumab vedotin (EV) and pembrolizumab (Pembro).\n\nThe names of the two study groups in this research study are:\n\n* Acupuncture + Virtual Exercise (AVE)\n* Virtual Exercise Only (VE)",[81,82,83,84,85,86],"Metastatic Bladder Cancer","Peripheral Neuropathy","Advanced Urothelial Cancer","Metastatic Urothelial Cancer","Bladder Cancer","Urothelial Cancer",[88,89,90,91],"Enfortumab Vedotin-Induced Neuropathy","Pembrolizumab-Induced Neuropathy","mUC","UC","2026-08-19",{"date":94,"type":95},"2026-08-20","ACTUAL",{"date":97,"type":75},"2026-08",{"date":99,"type":75},"2028-08",{"name":5,"class":6},1]