Breast CancerNCT07574671
Impact of Ketogenic Diet on Tumor Microenvironment in Patients With Breast Cancer
A study testing Ketogenic diet in people with Breast Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, 78229
Joseph Terrones, 210-450-5098, terronesj@uthscsa.edu
Kayla Chamberlin, RN, BSN, chamberlink@uthscsa.edu
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Ketogenic diet
- Keywords
- Ketogenic diet, diet, nutrition
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic dietOther
Also called KD
The ketogenic diet will be comprised of a low carbohydrate, high fat diet.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet Treatment arm | Experimental | Patients with early-stage breast cancer will adhere to a ketogenic diet for 3 weeks prior to surgery. Receives: Other: Ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tumor immune microenvironment
Measurement of ratio of M1 and M2 machrophages in the tumor micorenvironment
Measured: Baseline to 3 weeks
Secondary outcomes (3)
ketone level
percent time serum ketones ≥ 0.5 mmol/L
Measured: Baseline to 3 weeks
EORTC QLQ-30 (European Organization for Research and Treatment of Cancer) QLQ-30 Quality of life Questionnaire version 3)
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.
Measured: Baseline to 3 weeks
Fact B (The Functional Assessment of Cancer Therapy - Breast)
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)
Measured: Baseline to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start2 Apr 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-institution, window study
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Saba Shaikh, The University of Texas Health Science Center at San Antonio
- Investigators
- Saba Shaikh, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574671
- Sponsor's protocol ID
- CTMS# 25-0144
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ketogenic Diet on Tumor Microenvironment in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT07574671
- Acronym / sponsor ID
- CTMS# 25-0144
- Conditions
- Breast Cancer
- Keywords
- Ketogenic diet, diet, nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-institution, window study
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet Treatment arm | Experimental | Other: Ketogenic dietPatients with early-stage breast cancer will adhere to a ketogenic diet for 3 weeks prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic dietAlso: KDThe ketogenic diet will be comprised of a low carbohydrate, high fat diet. | Other | Ketogenic Diet Treatment arm |
Primary outcome
Change in tumor immune microenvironment
Time frame: Baseline to 3 weeks
Measurement of ratio of M1 and M2 machrophages in the tumor micorenvironment
3 secondary outcomes
ketone level
Time frame: 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
Fact B (The Functional Assessment of Cancer Therapy - Breast)
Time frame: Baseline to 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saba Shaikh, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic diet in people with Breast Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Terrones (210-450-5098, terronesj@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tumor immune microenvironment (time frame: Baseline to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.