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

May 4, 2026 updated by: Saba Shaikh, The University of Texas Health Science Center at San Antonio
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After screening for eligibility participants will meet with a dietitian who will provide education on a ketogenic diet (KD) along with additional educational material. Patients will adhere to a ketogenic diet for 3 weeks. Serum glucose and ketones will be measured by patients daily to assess adherence to KD. Patients will also keep a daily diary that will note food intake along with physical activity.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketogenic Diet Treatment arm
Patients with early-stage breast cancer will adhere to a ketogenic diet for 3 weeks prior to surgery.
Other: Ketogenic diet
The ketogenic diet will be comprised of a low carbohydrate, high fat diet.
Other Names:
  • KD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in tumor immune microenvironment
Time Frame: Baseline to 3 weeks
Measurement of ratio of M1 and M2 machrophages in the tumor micorenvironment
Baseline to 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ketone level
Time Frame: Baseline to 3 weeks
percent time serum ketones ≥ 0.5 mmol/L
Baseline to 3 weeks
EORTC QLQ-30 (European Organization for Research and Treatment of Cancer) QLQ-30 Quality of life Questionnaire version 3)
Time Frame: Baseline to 3 weeks
A 30 item instrument used to assess some of the different aspects that define the quality of life of cancer patients. The first 28 items are scored from 1=Not at all to 4=Very much and the last 2 items (reverse scored) rate overall quality of health and life from 1=Very poor to 7=Excellent. Total scores can range from 30-126 with a higher score indicating a better quality of life.
Baseline to 3 weeks
Fact B (The Functional Assessment of Cancer Therapy - Breast)
Time Frame: Baseline to 3 weeks
The Functional Assessment of Cancer Therapy - Breast (FACT-B) is a 37-item with each item scored from 0=Not at all to 4=Very much. The instrument is designed to measure five domains of HRQOL in breast cancer patients: Physical, social, emotional, functional well-being as well as a breast-cancer subscale (BCS) with total scores ranging from 0 to 148 (higher is better)
Baseline to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Saba Shaikh, MD, The University of Texas Health Science Center at San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

April 15, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMS# 25-0144

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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