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Ketogenic Diet for Early Breast Cancer

This study is looking at how a ketogenic diet affects the area around a tumor in patients with early-stage breast cancer. The ketogenic diet is a low-carbohydrate, high-fat eating plan. Researchers want to see if this diet changes the tumor's immune microenvironment (the cells and molecules surrounding the tumor) from the start of the study to 3 weeks later. You might be able to join if you are at least 18 years old, postmenopausal, and have Stage I or II breast cancer. The study plans to enroll 12 participants, but its current recruitment status is unclear.

Study design
This is an interventional study with an unclear phase, planning to enroll 12 participants.
What's involved
You would follow a ketogenic diet for 3 weeks, meet with a dietitian for education, and keep a daily diary of food intake and physical activity. You would also measure your blood sugar and ketones daily.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 3 weeks after baseline.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07574671

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

Recruiting
NAAges 18+InterventionalBasic science
The University of Texas Health Science Center at San Antonio
~12 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Ketogenic diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in tumor immune microenvironment
Measured over Baseline to 3 weeks

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Saba Shaikh, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio

Who to contact

Joseph Terrones
[email protected]
210-450-5098
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in tumor immune microenvironmentBaseline to 3 weeks

    Measurement of ratio of M1 and M2 machrophages in the tumor micorenvironment