[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05417867":3,"trial-entities:NCT05417867":151,"trial-summary:NCT05417867":155},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":45,"secondary_outcomes":69,"sex":70,"minimum_age":71,"maximum_age":25,"healthy_volunteers":15,"eligibility_criteria":72,"std_ages":83,"locations":86,"central_contacts":142,"overall_officials":143,"references":146,"see_also_links":147},"NCT05417867","20-009279","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","RECRUITING","2027-03-31","2026-03","2026-03-31","2021-04-14","Mayo Clinic","OTHER",false,"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.","PRIMARY OBJECTIVES:\n\nI. Evaluate the feasibility of patient recruitment and retention, as well as specimen collection.\n\nII. Estimate the effect size for changes in gut microbiome composition profiles and metabolites in stool as well as blood from time of first stool sample collection prior to chemotherapy (T1) to time of second stool sample collection after chemotherapy (T2) that are associated with the occurrence of fatigue and CIN.\n\nIII. Evaluate associations between patient reported demographic and clinical characteristics, comorbidities at T1, and changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 with the occurrence of fatigue and CIN.\n\nOUTLINE: This is an observational study.\n\nPatients undergo collection of stool and blood samples and complete questionnaires on study.",[19,20,21,22],"Chemotherapy-Related Nausea and\u002For Vomiting","Early Stage Breast Carcinoma","Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8",[],"OBSERVATIONAL",null,[],{"count":28,"type":29},70,"ESTIMATED",[31,41],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"PROCEDURE","Biospecimen Collection","Undergo collection of stool and blood samples",[36],"Observational",[38,39,40],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":14,"name":42,"description":43,"armGroupLabels":44},"Questionnaire Administration","Complete questionnaires",[36],[46,50,52,55,57,61,64,67],{"measure":47,"description":48,"timeFrame":49},"Number of patients approached","Assessed using descriptive statistics.","Up to 24 months",{"measure":51,"description":48,"timeFrame":49},"Number of patients enrolled",{"measure":53,"description":48,"timeFrame":54},"Number of patients who completed the questionnaires at both assessments","At baseline and 3-5 days after initiation of chemotherapy",{"measure":56,"description":48,"timeFrame":54},"Number of patients who provided stool samples at both assessments",{"measure":58,"description":59,"timeFrame":60},"Bacterial composition of stool samples","All stool samples will be processed for deoxyribonucleic acid extraction. The hypervariable regions V3 and V4 of the bacterial 16S ribosomal ribonucleic acid (rRNA) gene will be sequenced to determine bacterial composition. After quality control, 16S rRNA reads will be analyzed to determine operational taxonomic units (OTU) for T1 and T2 samples using QIIME software. Alpha (within sample) diversity and beta (between sample) diversity will be analyzed using nonmetric multidimensional scaling ordination and the effect size for changes in OTUs in gut microbiome composition profiles from T1 to T2 in patients who do and do not report fatigue or chemotherapy-induced nausea (CIN) at T2 as measured by questionnaire.","Up to study completion",{"measure":62,"description":63,"timeFrame":60},"Differences in demographic between patients who do and do not report fatigue and CIN","Evaluated using parametric and non-parametric tests. The changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 associated with the occurrence of fatigue and CIN will be evaluated.",{"measure":65,"description":66,"timeFrame":60},"Differences in clinical characteristics between patients who do and do not report CIN","Evaluated using parametric and non-parametric tests. The changes in gastrointestinal and neuropsychological symptoms, food intake as well as exercise from T1 to T2 associated with the occurrence of CIN will be evaluated.",{"measure":68,"description":66,"timeFrame":60},"Differences in comorbidities between patients who do and do not report CIN",[],"ALL","20 Years",{"inclusion":73,"exclusion":78,"raw_text":82},[74,75,76,77],"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","At least 20 years of age","Last chemotherapy more than 3 years ago","Scheduled to receive moderate to highly emetogenic chemotherapy with or without targeted therapies including immunotherapies",[79,80,81],"Metastatic disease","Concurrent radiation therapy","Concurrent antibiotic treatment","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",[84,85],"ADULT","OLDER_ADULT",[87,97,106,123,135],{"facility":88,"status":89,"city":90,"state":91,"zip":92,"country":93,"geoPoint":94},"Mayo Clinic in Arizona","SUSPENDED","Scottsdale","Arizona","85259","United States",{"lat":95,"lon":96},33.50921,-111.89903,{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":93,"geoPoint":103},"Mayo Clinic in Florida","ACTIVE_NOT_RECRUITING","Jacksonville","Florida","32224-9980",{"lat":104,"lon":105},30.33218,-81.65565,{"facility":107,"status":8,"city":108,"state":109,"zip":110,"country":93,"contacts":111,"geoPoint":120},"Mayo Clinic Health System in Albert Lea","Albert Lea","Minnesota","56007",[112,117],{"name":113,"role":114,"phone":115,"email":116},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",{"name":118,"role":119},"Mina Hanna, MD","PRINCIPAL_INVESTIGATOR",{"lat":121,"lon":122},43.64801,-93.36827,{"facility":124,"status":8,"city":125,"state":109,"zip":126,"country":93,"contacts":127,"geoPoint":132},"Mayo Clinic Health System in Mankato","Mankato","56001",[128,130],{"name":113,"role":114,"phone":129,"email":116},"612-624-2620",{"name":131,"role":119},"Amrit B. Singh, MBBS",{"lat":133,"lon":134},44.15906,-94.00915,{"facility":136,"status":89,"city":137,"state":109,"zip":138,"country":93,"geoPoint":139},"Mayo Clinic in Rochester","Rochester","55905",{"lat":140,"lon":141},44.02163,-92.4699,[],[144],{"name":145,"affiliation":13,"role":119},"Brenda J. Ernst, MD",[],[148],{"label":149,"url":150},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":152,"biomarkers":154},[153],"Breast Carcinoma",[],{"nct_id":4,"found":156,"summary":157,"prompt_version":167},true,{"design":158,"status":159,"heading":160,"summary":161,"follow_up":162,"word_count":163,"commitments":164,"compensation":165,"drugs_mentioned":166},"This is an observational study aiming to enroll 70 participants. It will look at how changes in the gut microbiome are associated with fatigue and chemotherapy-induced nausea.","completed","Observational Study on Gut Microbiome, Fatigue, and Nausea in Early Breast Cancer","This study is looking at how changes in the bacteria in your gut (gut microbiome) might be linked to feeling tired (fatigue) and having nausea caused by chemotherapy in people with early-stage breast cancer. Many people experience fatigue or nausea during chemotherapy, but we don't fully understand why some people have it more than others. Researchers believe that changes in your gut microbiome could play a role. If you have early-stage breast cancer and are planning to receive chemotherapy, you might be able to join. The study involves collecting stool and blood samples, and filling out questionnaires. The main goal is to see how many people can be recruited and stay in the study, and to estimate how much the gut microbiome changes in relation to fatigue and nausea.","The study will measure the number of patients approached and enrolled for up to 24 months.",129,"You would provide stool and blood samples and complete questionnaires at the start of chemotherapy and again 3-5 days after starting chemotherapy.","Not stated in the trial record.",[],"v2"]