RecruitingNot ApplicableNCT07574671

Impact of Ketogenic Diet on Tumor Microenvironment in Patients With Breast Cancer

Sponsor

The University of Texas Health Science Center at San Antonio

Enrollment

12 participants

Start Date

Apr 2, 2026

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

Be willing and able to provide consent for the study
Age ≥ 18 on the day consent is obtained
Eastern Cooperative Oncology Group (ECOG) score ≤ 2
Patients must be postmenopausal the time of study entry
Stage I or II breast cancer using Tumor, Nodes and Metastasis (TNM) stage groups per American Joint Committee on Cancer (AJCC) 8th edition
Plan for upfront breast surgery with mastectomy or partial mastectomy and does not require pre-operative systemic therapy per standard of care
Must have tissue available from initial breast biopsy performed per standard of care
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/ketones at home, accurately log food intake and exercise, prepare food that is in line with ketogenic diet

Exclusion Criteria24

Clinical indication for neoadjuvant therapy
Partial mastectomy or mastectomy planned for less than 3 weeks from study entry
Inability to comply with ketogenic diet
Consistent use of ketogenic diet within past 3 months
Participation in another diet program during study period
Nonepithelial breast malignancy such as sarcoma or lymphoma
Body Mass Index < 18.5
Comorbidities and/or active or ongoing illness that in the opinion of the investigator will limit patient's ability to safely participate in study
Type I diabetes
Use of insulin or other oral hypoglycemic drugs for diabetes
Has had any of the following within the past 6 months
Myocardial infarction or unstable angina
Ventricular arrythmia
Acute decompensated heart failure
Cerebrovascular accident
Hypertensive emergency
Uncontrolled hypertension despite antihypertensive use
End-stage renal, liver, or cardiac disease
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)
G6PD (glucose-6-phosphate dehydrogenase) deficiency
Malabsorption syndromes (such as but not limited to inflammatory bowel disease, history of gastric sleeve, prior bowel resection)
History of recurrent kidney stones or predisposition to kidney stones
Triglycerides ≥ 500
Has known psychiatric or substance use disorders that would interfere with participation in the study