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

NCT07574671 | Recruiting DMC

• 1 other identifier: CTMS# 25-0144
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Ketogenic diet; diet; nutrition

Outcome Measures

Primary Outcomes (1)

• Change in tumor immune microenvironment

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

  Baseline to 3 weeks

Secondary Outcomes (3)

• ketone level

  Baseline to 3 weeks

• EORTC QLQ-30 (European Organization for Research and Treatment of Cancer) QLQ-30 Quality of life Questionnaire version 3)

  Baseline to 3 weeks

• Fact B (The Functional Assessment of Cancer Therapy - Breast)

  Baseline to 3 weeks

Study Arms (1)

Ketogenic Diet Treatment arm

EXPERIMENTAL

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

Other: Ketogenic diet

Interventions

Ketogenic diet OTHER

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

Also known as: KD

Ketogenic Diet Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Saba Shaikh, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Terrones

CONTACT

210-450-5098; terronesj@uthscsa.edu

Kayla Chamberlin, RN, BSN

CONTACT

210-450-5964; chamberlink@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective, single-institution, window study

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 8, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-04

Locations

US (1)