Actively Recruiting
Impact of Ketogenic Diet on Tumor Microenvironment in Patients With Breast Cancer
Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-05-08
12
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Ketogenic Diet on Tumor Microenvironment in Patients With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide consent for the study
- Age 18 years or older on the day consent is obtained
- Eastern Cooperative Oncology Group (ECOG) score of 2 or less
- Must be postmenopausal at the time of study entry
- Diagnosed with stage I or II breast cancer according to AJCC 8th edition
- Planned upfront breast surgery with mastectomy or partial mastectomy without pre-operative systemic therapy
- Availability of tissue from initial breast biopsy performed per standard care
- Ability to adhere to ketogenic diet and comply with study requirements, including telemedicine participation, use of smart device apps, home glucose/ketone measurement, accurate logging of food intake and exercise, and food preparation compatible with the ketogenic diet
You will not qualify if you...
- Clinical indication for neoadjuvant therapy
- Planned surgery 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
- Non-epithelial breast malignancy such as sarcoma or lymphoma
- Body Mass Index less than 18.5
- Comorbidities or active illness limiting safe participation as judged by investigator
- Type I diabetes
- Use of insulin or oral hypoglycemic drugs for diabetes
- History of myocardial infarction, unstable angina, ventricular arrhythmia, acute decompensated heart failure, cerebrovascular accident, or hypertensive emergency within past 6 months
- Uncontrolled hypertension despite treatment
- End-stage renal, liver, or cardiac disease
- Genetic disorders affecting lipid metabolism
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Malabsorption syndromes or history of gastric sleeve or bowel resection
- History or predisposition to kidney stones
- Triglycerides 500 or higher
- Known psychiatric or substance use disorders interfering with participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
J
Joseph Terrones
CONTACT
K
Kayla Chamberlin, RN, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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