Who is eligible for clinical trial NCT07574671?

Participants must meet protocol criteria for Breast Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07574671 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-04

Impact of Ketogenic Diet on Tumor Microenvironment in Patients With Breast Cancer (NCT07574671)

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: The University of Texas Health Science Center at San Antonio

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (25 items).

Location: Mays Cancer Center, UT Health San Antonio — San Antonio, Texas

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Mays Cancer Center, UT Health San Antonio — San Antonio, Texas

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗