[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471360":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":10,"locations":33,"responsibleParty":101,"collaborators":10,"id":103,"slug":10,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":10,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":10,"enrollmentInfo":111,"targetDuration":10,"studyType":114,"phases":10,"briefSummary":115,"conditions":116,"keywords":10,"overallStatus":61,"whyStopped":10,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Observational",null,"Patients undergo collection of stool and blood samples and complete questionnaires on study.",[13,14],"Procedure: Biospecimen Collection","Other: Questionnaire Administration",[16,25],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"PROCEDURE","Biospecimen Collection","Undergo collection of stool and blood samples",[9],[22,23,24],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Questionnaire Administration","Complete questionnaires",[9],[30],{"name":31,"affiliation":5,"role":32},"Brenda J. Ernst, MD","PRINCIPAL_INVESTIGATOR",[34,48,59,78,92],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":10},"Mayo Clinic in Arizona","SUSPENDED","Scottsdale","Arizona","85259","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-111.89903,33.50921,{"lat":46,"lon":45},{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":40,"countryCode":41,"cosmosGeoPoint":54,"geoPoint":58,"contacts":10},"Mayo Clinic in Florida","ACTIVE_NOT_RECRUITING","Jacksonville","Florida","32224-9980",{"type":43,"coordinates":55},[56,57],-81.65565,30.33218,{"lat":57,"lon":56},{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":40,"countryCode":41,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Mayo Clinic Health System in Albert Lea","RECRUITING","Albert Lea","Minnesota","56007",{"type":43,"coordinates":66},[67,68],-93.36827,43.64801,{"lat":68,"lon":67},[71,76],{"name":72,"role":73,"phone":74,"phoneExt":10,"email":75},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",{"name":77,"role":32,"phone":10,"phoneExt":10,"email":10},"Mina Hanna, MD",{"facility":79,"status":61,"city":80,"state":63,"zip":81,"country":40,"countryCode":41,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Mayo Clinic Health System in Mankato","Mankato","56001",{"type":43,"coordinates":83},[84,85],-94.00915,44.15906,{"lat":85,"lon":84},[88,90],{"name":72,"role":73,"phone":89,"phoneExt":10,"email":75},"612-624-2620",{"name":91,"role":32,"phone":10,"phoneExt":10,"email":10},"Amrit B. Singh, MBBS",{"facility":93,"status":36,"city":94,"state":63,"zip":95,"country":40,"countryCode":41,"cosmosGeoPoint":96,"geoPoint":100,"contacts":10},"Mayo Clinic in Rochester","Rochester","55905",{"type":43,"coordinates":97},[98,99],-92.4699,44.02163,{"lat":99,"lon":98},{"type":102,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100471360",false,"NCT05417867","Evaluating the Association Among Changes in Gut Microbiome, Fatigue, and Chemotherapy-Induced Nausea in Early Stage Breast Cancer","Associations of Fatigue and Chemotherapy-Induced Nausea With Changes in Gut Microbiome Composition Profiles","Inclusion Criteria:\n\n* Subjects with a diagnosis of early stage breast cancer planning to receive moderate to highly emetogenic chemotherapy will be recruited at Mayo Clinic Health Systems including Mankato and Albert Lea; Mayo Clinic Arizona; Mayo Clinic Rochester (Minnesota); and Mayo Clinic Florida\n* At least 20 years of age\n* Last chemotherapy more than 3 years ago\n* Scheduled to receive moderate to highly emetogenic chemotherapy with or without targeted therapies including immunotherapies\n\nExclusion Criteria:\n\n* Metastatic disease\n* Concurrent radiation therapy\n* Concurrent antibiotic treatment","ALL","20 Years",{"count":112,"type":113},70,"ESTIMATED","OBSERVATIONAL","This pilot study seeks to understand how changes in the bacteria composition (microbiome) of the gut may be associated with the occurrence of fatigue and chemotherapy-induced nausea (CIN) in women undergoing chemotherapy for early stage breast cancer. Patients undergoing chemotherapy may experience fatigue or nausea as a result of their treatment. Known risk factors for fatigue and CIN do not explain the differences in fatigue and CIN occurrence between patients, but changes in the functions of the gut microbiome may be related to the occurrence of fatigue and CIN. This study collects stool samples from breast cancer patients before and after chemotherapy to evaluate how changes in the microbiome may be associated with fatigue and CIN.",[117,118,119,120],"Chemotherapy-Related Nausea and\u002For Vomiting","Early Stage Breast Carcinoma","Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","2026-03-26",{"date":123,"type":124},"2026-03-31","ACTUAL",{"date":126,"type":124},"2021-04-14",{"date":128,"type":113},"2027-03-31",{"name":5,"class":6},5]