Ketogenic diet before surgery for early-stage breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Eligible participants will meet with a dietitian and receive education and materials to follow a ketogenic diet for three weeks before their planned breast surgery. Participants will measure blood glucose and ketones daily at home and keep a food and activity diary to document adherence. Surgical tissue from the planned upfront operation will be used to examine changes in the tumor microenvironment. The study enrolls adults with stage I–II disease who do not require preoperative systemic therapy and are able to follow the diet and remote monitoring procedures.

Why it matters

Who can join: the full rules

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 it's running

• Mays Cancer Center, UT Health San Antonio
  San Antonio, Texas, United States Recruiting

Study contacts

• Principal investigator: Saba Shaikh, MD — The University of Texas Health Science Center at San Antonio
• Study coordinator: Joseph Terrones
• Email: terronesj@uthscsa.edu
• Phone: 210-450-5098

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.