NCT07574671 · The University of Texas Health Science Center at San Antonio
Impact of Ketogenic Diet on Tumor Microenvironment in Patients With Breast Cancer
What this study 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.
View original scientific description
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.
Interventions
OTHER
Ketogenic diet
The ketogenic diet will be comprised of a low carbohydrate, high fat diet.
Primary outcome measures
Change in tumor immune microenvironment
Time frame: Baseline to 3 weeks
Measurement of ratio of M1 and M2 machrophages in the tumor micorenvironment
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- San Antonio, Texas
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2026 · Source of record for eligibility and locations