[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639844":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":36,"responsibleParty":54,"collaborators":57,"id":61,"slug":30,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":30,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":30,"enrollmentInfo":68,"targetDuration":30,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":39,"whyStopped":30,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"The University of Texas Health Science Center at San Antonio","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketogenic Diet Treatment arm","EXPERIMENTAL","Patients with early-stage breast cancer will adhere to a ketogenic diet for 3 weeks prior to surgery.",[13],"Other: Ketogenic diet",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Ketogenic diet","The ketogenic diet will be comprised of a low carbohydrate, high fat diet.",[9],[20],"KD",[22],{"name":23,"affiliation":5,"role":24},"Saba Shaikh, MD","PRINCIPAL_INVESTIGATOR",[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Joseph Terrones","CONTACT","210-450-5098",null,"terronesj@uthscsa.edu",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Kayla Chamberlin, RN, BSN","210-450-5964","chamberlink@uthscsa.edu",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Mays Cancer Center, UT Health San Antonio","RECRUITING","San Antonio","Texas","78229","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-98.49363,29.42412,{"lat":49,"lon":48},[52,53],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},{"name":33,"role":28,"phone":30,"phoneExt":34,"email":35},{"type":24,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Saba Shaikh","Assistant Professor",[58],{"name":59,"class":60},"National Cancer Institute (NCI)","NIH","100639844",false,"NCT07574671","Impact of Ketogenic Diet on Tumor Microenvironment in Patients With Breast Cancer","Inclusion Criteria:\n\n* Be willing and able to provide consent for the study\n* Age ≥ 18 on the day consent is obtained\n* Eastern Cooperative Oncology Group (ECOG) score ≤ 2\n* Patients must be postmenopausal the time of study entry\n* Stage I or II breast cancer using Tumor, Nodes and Metastasis (TNM) stage groups per American Joint Committee on Cancer (AJCC) 8th edition\n* Plan for upfront breast surgery with mastectomy or partial mastectomy and does not require pre-operative systemic therapy per standard of care\n* Must have tissue available from initial breast biopsy performed per standard of care\n* have the ability in the opinion of the investigator to adhere to a ketogenic diet and comply with study requirements such as ability to participate in telemedicine, utilize apps on a smart device, measure glucose\u002Fketones at home, accurately log food intake and exercise, prepare food that is in line with ketogenic diet\n\nExclusion Criteria:\n\n* Clinical indication for neoadjuvant therapy\n* Partial mastectomy or mastectomy planned for less than 3 weeks from study entry\n* Inability to comply with ketogenic diet\n* Consistent use of ketogenic diet within past 3 months\n* Participation in another diet program during study period\n* Nonepithelial breast malignancy such as sarcoma or lymphoma\n* Body Mass Index \\\u003C 18.5\n* Comorbidities and\u002For active or ongoing illness that in the opinion of the investigator will limit patient's ability to safely participate in study\n* Type I diabetes\n* Use of insulin or other oral hypoglycemic drugs for diabetes\n* Has had any of the following within the past 6 months\n\n  * Myocardial infarction or unstable angina\n  * Ventricular arrythmia\n  * Acute decompensated heart failure\n  * Cerebrovascular accident\n  * Hypertensive emergency\n* Uncontrolled hypertension despite antihypertensive use\n* End-stage renal, liver, or cardiac disease\n* genetic disorders that affect lipid metabolism (example: pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, beta-oxidation defects, among others)\n* G6PD (glucose-6-phosphate dehydrogenase) deficiency\n* Malabsorption syndromes (such as but not limited to inflammatory bowel disease, history of gastric sleeve, prior bowel resection)\n* History of recurrent kidney stones or predisposition to kidney stones\n* Triglycerides ≥ 500\n* Has known psychiatric or substance use disorders that would interfere with participation in the study","ALL","18 Years",{"count":69,"type":70},12,"ESTIMATED","INTERVENTIONAL",[73],"NA","This study is testing the effects of a ketogenic diet on patients with early stage breast cancer. Participants will keep to a ketogenic diet for 3 weeks prior to surgery.",[76],"Breast Cancer",[16,78,79],"diet","nutrition","2026-05-04",{"date":82,"type":83},"2026-05-08","ACTUAL",{"date":85,"type":83},"2026-04-02",{"date":87,"type":70},"2028-04",{"name":5,"class":6},1]