Impact of Ketogenic Diet on Tumor Microenvironment in Patients With Breast Cancer
Recruiting now · Not applicable
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT07574671
- Run by
- The University of Texas Health Science Center at San Antonio
- People needed
- 12
- Starts
- 2026-04-02
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Mays Cancer Center, UT Health San Antonio — San Antonio, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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