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Can a keto diet change breast cancer tumors?

NCT ID NCT07574671

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how a ketogenic (high-fat, low-carb) diet affects the area around breast cancer tumors. Twelve postmenopausal women with early-stage breast cancer will follow the diet for 3 weeks before their surgery. Researchers will measure changes in immune cells and ketone levels to see if the diet alters the tumor environment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mays Cancer Center, UT Health San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

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