[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557343":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":54,"collaborators":56,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":20,"enrollmentInfo":72,"targetDuration":20,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":20,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fasting prior to chemotherapy","EXPERIMENTAL","Prior to chemotherapy administration, a trial of a 24-hour water-only fast will be conducted; at least 1 successful 24-hour fast is required to proceed with the fasting intervention during chemotherapy. A total of 3 trials is allowed (for a maximum of 48 hours fasting).",[13],"Behavioral: Fasting",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BEHAVIORAL","Fasting","The dietician will review the patient's chemotherapy schedule, and confirm the fasting window (as windows may be 24, 26 or 48 hours; and chemotherapy start times can vary from patient to patient).",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Jennifer Sheng, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","202-537-4000","jsheng7@jhmi.edu",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Sibley Memorial Hospital","RECRUITING","Washington D.C.","District of Columbia","20016","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-77.03637,38.89511,{"lat":43,"lon":42},[46,50],{"name":47,"role":27,"phone":48,"phoneExt":20,"email":49},"Azka Tariq","202-660-5712","atariq6@jhmi.edu",{"name":51,"role":27,"phone":52,"phoneExt":20,"email":53},"Aliya Lalji","202-243-2294","alalji1@jhmi.edu",{"type":55,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[57,59],{"name":58,"class":6},"The Commonwealth Fund",{"name":60,"class":61},"Maryland Cigarette Restitution Fund","OTHER_GOV","100557343","gut-microbiome-adverse-effects-and-markers-through-metabolic-reprogramming-100557343",false,"NCT06536881","Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming","Gut Microbiome, Adverse Effects, and Markers Through MEtabolic Reprogramming (GAMMER) Study in Early Stage Breast Cancer Receiving Chemotherapy","GAMMER","Inclusion Criteria:\n\n* Diagnosed with histologically-confirmed stage I-III invasive carcinoma of the breast\n* Planning for standard neoadjuvant or adjuvant chemotherapy ddAC or TC for 4 cycles (concurrent anti-HER2 therapy is permitted)\n* Provider physical exam within 4 weeks of consent\n* Eastern Cooperative Oncology Group (ECOG) 0-1 (as per recent provider note or direct confirmation with provider)\n* BMI ≥ 19.5 kg\u002Fm2 (as per most recent visit documented in medical record)\n* Willingness to change diet, and provide fecal sample 3 times during study\n\nExclusion Criteria:\n\n* BMI \\\u003C19.5 kg\u002Fm2\n* Diabetes\n* History of eating disorder\n* Serious\u002Funcontrolled medical condition (e.g. end stage renal disease on dialysis, cirrhosis, uncontrolled hypertension, seizure disorder, history of bariatric surgery)\n* Pregnant or nursing\n* Use of medications that must be taken with food: allopurinol, aspirin, amiodarone, baclofen, bromocriptine, carvedilol, carbamezpine, cimetidine, diclofenac, doxycycline, fenofibrate, fludrocortisone, glyburide, hydrocortisone, iron supplements, ketorolac, lithium, methylprednisolone, naproxen, niacin, potassium salts, prednisone, procainamide, sevelamer, sulfasalazine, trazodone, valproic acid","FEMALE","18 Years",{"count":73,"type":74},30,"ESTIMATED","INTERVENTIONAL",[77],"NA","This research is being done to test the feasibility of 24-48 hours of water-only fasting to improve delivery of 4 cycles of chemotherapy in those receiving breast cancer treatment either before or after surgery.",[80,81],"Breast Cancer","Early-stage Breast Cancer","2026-08-19",{"date":84,"type":85},"2026-08-21","ACTUAL",{"date":87,"type":85},"2024-08-08",{"date":89,"type":74},"2029-05",{"name":5,"class":6},1]