Recruiting

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

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT07574671

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ketogenic diet

Study Details

Brief 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.

Conditions

Breast Cancer

Study ID

NCT07574671

Start date

Apr 2, 2026

Status verified date

Apr, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Ketogenic Diet Treatment arm

Patients with early-stage breast cancer will adhere to a ketogenic diet for 3 weeks prior to surgery.

Interventions

Ketogenic diet

The ketogenic diet will be comprised of a low carbohydrate, high fat diet.

Primary outcome measure

Change in tumor immune microenvironment [ Time Frame: Baseline to 3 weeks ]

Central Contacts and Locations

Central contacts

Joseph Terrones

210-450-5098 terronesj@uthscsa.edu

Kayla Chamberlin, RN, BSN

210-450-5964 chamberlink@uthscsa.edu

Locations

Mays Cancer Center, UT Health San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Joseph Terrones

210-450-5098 terronesj@uthscsa.edu

Kayla Chamberlin, RN, BSN

chamberlink@uthscsa.edu

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

May 8, 2026

Last verified

Apr, 2026

Keywords

Ketogenic diet
diet
nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-05-08.