[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631387":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":28,"locations":34,"responsibleParty":52,"collaborators":25,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":25,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":36,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Florida State University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active taVNS intervention","ACTIVE_COMPARATOR","practice the active taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)",[13],"Device: Active taVNS",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham taVNS","SHAM_COMPARATOR","practice the sham taVNS twice daily for 30 minutes each over a 4-week period (56 sessions)",[19],"Device: Sham taVNS",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DEVICE","Active taVNS",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":25,"email":33},"Jie Chen","CONTACT","850-645-0657","jc22db@fsu.edu",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Tallahassee","Florida","32306","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-84.28073,30.43826,{"lat":46,"lon":45},[49],{"name":50,"role":31,"phone":51,"phoneExt":25,"email":33},"JIE CHEN","8506450657",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Jie Chen, PhD, RN","Principal Investigator","100631387","tavns-for-breast-cancer-pain-and-symptom-management-100631387",false,"NCT07500012","taVNS for Breast Cancer Pain and Symptom Management","Home-based Pain and Symptom Management for Breast Cancer Survivors: a Triple- Blinded RCT Pilot Study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)","Inclusion Criteria:\n\n1. are aged 18-79 years older;\n2. have histologically confirmed Stage 0, I, II, or III breast cancer;\n3. had completed their primary cancer treatment (surgery, radiotherapy, chemotherapy) and are currently on a stable survivorship care plan (e.g., endocrine therapy, supportive care), with no major treatment changes expected during the study;\n4. have experienced pain with a severity of 4 or greater out of 10 for at least ten days in the last month;\n5. are committed to maintaining the current treatment plan (e.g., endocrine therapy, supportive care) during the study;\n6. have reliable internet access;\n7. are willing to provide stool samples and undergo fNIRS brain imaging procedures;\n8. are able to read and understand English and provide written informed consent.\n\nExclusion Criteria:\n\n1. have metastatic breast cancer (Stage IV);\n2. have a current diagnosis of another active cancer;\n3. have a history of significant cardiac conditions, such as bradycardia, arrhythmia, recent myocardial infarction, or heart failure;\n4. have been diagnosed with a severe psychiatric illness (e.g., schizophrenia, bipolar I disorder with active psychosis) that could interfere with adherence to study procedures;\n5. have active inflammatory or malabsorptive gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, celiac disease) that could confound gut microbiota results;\n6. have taken antibiotics, probiotics, or gastrointestinal motility agents (e.g., laxatives, prokinetics) within the past 3 months, due to potential disruption of gut microbiota;\n7. have a progressive neurological condition (e.g., Parkinson's disease, epilepsy, multiple sclerosis) that may impact fNIRS data quality or study participation;\n8. have a history of surgical or pharmacological vagotomy or are currently receiving implanted vagus nerve stimulation therapy, because of potential interference with autonomic regulation and taVNS mechanisms;\n9. have an active electronic or metallic implant (e.g., cochlear implant, pacemaker, neurostimulator) or other electronic\u002Fmetallic device in the head or neck area, which may be contraindicated for taVNS;\n10. are pregnant, breastfeeding, or planning to become pregnant during the study period;\n11. have had a recent initiation or dose change of pain medications (e.g., opioids, neuropathic agents) within the past 4 weeks.","FEMALE","18 Years","79 Years",{"count":67,"type":68},40,"ESTIMATED","INTERVENTIONAL",[71],"NA","1. To evaluate the feasibility and acceptability of a home-based taVNS intervention and follow-up for pain and symptom management in breast cancer survivors.\n2. To investigate the impact of taVNS on secondary outcomes, including pain, anxiety, depression, fatigue, and the brain-gut axis (BGA) in breast cancer survivors.",[74],"Breast Cancer Survivors",[76,77,78],"pain","symptoms","transcutaneous auricular vagus nerve stimulation (taVNS)","2026-03-25",{"date":81,"type":82},"2026-03-30","ACTUAL",{"date":84,"type":82},"2026-02-24",{"date":86,"type":68},"2028-02",{"name":5,"class":6},1]