[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562971":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":38,"responsibleParty":64,"collaborators":66,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":12,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":12,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":40,"whyStopped":12,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Scripps Health","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Educational Handout","NO_INTERVENTION","Participants will receive usual standard of care for early-stage triple negative breast cancer and an educational handout on increasing dietary fiber.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"High Fiber Dietary Counseling","EXPERIMENTAL","Participants will receive usual standard of care for early-stage triple negative breast cancer and personalized nutritional counseling (initial 1 hour session with up to 2 30-minute follow-up sessions) on how to increase dietary fiber.",[18],"Other: Nutritional Counseling",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"Nutritional Counseling","The nutritional intervention for the treatment group -- personalized counseling on increasing fiber intake and maintaining adequate caloric intake during treatment -- will be administered as (1) a 60-minute initial telehealth consultation within the first week of study enrollment, and (2) up to two 30-minute follow-ups throughout the study, ideally the first follow-up within 6 weeks of study enrollment. These sessions will be led by a registered dietitian using cultural awareness and symptom assessment.",[14],[25],{"name":26,"affiliation":27,"role":28},"Lee Hong, MD, PhD","Scripps Clinic","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":12,"email":33},"CONTACT","858-610-1321","hong.lee@scrippshealth.org",{"name":35,"role":31,"phone":36,"phoneExt":12,"email":37},"Thomas Buchholz, MD","858-678-7190","buchholz.thomas@scrippshealth.org",[39],{"facility":27,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","La Jolla","California","92037","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-117.2742,32.84727,{"lat":50,"lon":49},[53,55,56,57,60,62],{"name":26,"role":31,"phone":54,"phoneExt":12,"email":33},"858-554-8788",{"name":35,"role":31,"phone":12,"phoneExt":12,"email":37},{"name":26,"role":28,"phone":12,"phoneExt":12,"email":12},{"name":58,"role":59,"phone":12,"phoneExt":12,"email":12},"Jacob New, MD, PhD","SUB_INVESTIGATOR",{"name":61,"role":59,"phone":12,"phoneExt":12,"email":12},"Gagandeep Kaur, DO",{"name":63,"role":59,"phone":12,"phoneExt":12,"email":12},"Laura Nicholson, MD, PhD",{"type":65,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[67,69],{"name":68,"class":6},"San Diego State University",{"name":70,"class":6},"The Scripps Research Institute","100562971","tnbc-gut-microbiota-during-neoadjuvant-treatment-100562971",false,"NCT06610097","TNBC Gut Microbiota During Neoadjuvant Treatment","Impacts of Diet, Activity, and Mood on a Dynamic Gut Microbiota During Treatment for Triple-negative Breast Cancer","Inclusion Criteria:\n\n* Diagnosis of early-stage triple-negative breast cancer, not on neoadjuvant systemic therapy at the time of enrollment.\n* Age greater than or equal to 18 years and less than 100 years\n* English proficiency at or above 8th grade level\n* Expected survival greater than or equal to 12 months\n\nExclusion Criteria:\n\n* Prebiotic and\u002For probiotic use prior to and during the study","ALL","18 Years","100 Years",{"count":82,"type":83},30,"ESTIMATED","INTERVENTIONAL",[86],"NA","The gut microbiome is made up of the microbes (such as bacteria, viruses, and other organisms too small to see with the naked eye) that live in the digestive tract and has been shown to be important in metabolizing food, extracting vitamins and nutrients from food, and maintaining a healthy gut lining. The gut microbiome plays an important role in overall health and has been shown to dynamically change in response to early-stage triple-negative breast cancer-directed therapies, which in turn has been associated with worse outcomes. As the gut microbiome can be further modulated with dietary changes during cancer treatment, it is an ideal potential modifiable risk factor in cancer patients. However, due to multiple confounding factors such as dietary intake, mood, and activity, its utility as part of the oncologic clinical assessment remains unclear.\n\nIn this prospective randomized controlled study, the investigators propose to recruit up to 30 early-stage TNBC patients to randomize to a personalized nutritional intervention of a high-fiber diet coached by a registered dietician versus educational handout alone during neoadjuvant treatment. The investigators propose to study the gut microbiota through stool sample analysis among early-stage triple-negative breast cancer patients undergoing neoadjuvant (i.e. before surgery) chemotherapy +\u002F- immunotherapy. The investigators will also study how the gut microbiota can be further modulated with a high-fiber diet, and the investigators hypothesize that a high-fiber diet may play a protective role in preserving gut microbial diversity. As part of the nutritional intervention, the investigators propose to administer nutritional counseling with a registered dietitian (RD) to increase fiber intake and tracking performance status, activity, and mood during neoadjuvant treatment. Finally, the investigators propose to survey participants after study completion through one-on-one interviews to determine whether participants experienced improved overall patient satisfaction in supportive care during their treatment.",[89,90,91],"Breast Cancer","Triple Negative Breast Cancer","Early Stage Triple-Negative Breast Carcinoma",[93,94,95,96],"gut microbiome","triple-negative breast cancer","high fiber diet","immunotherapy","2025-04-21",{"date":99,"type":100},"2025-04-23","ACTUAL",{"date":102,"type":100},"2025-03-07",{"date":104,"type":83},"2026-06-30",{"name":5,"class":6},1]