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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients will adhere to a ketogenic diet for 3 weeks."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how a ketogenic diet—a high-fat, very low-carb diet—affects breast cancer and the area around the tumor. It is for adults who have gone through menopause and have stage I or II breast cancer. Participants follow the diet for 3 weeks before surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and willing and able to give consent.
  • Have gone through menopause.
  • Have stage I or II breast cancer.
  • Have an ECOG activity score of 0–2: be able to care for yourself and be up and about at least half the day.
  • Plan to have all or part of the breast removed, without needing drug treatment before surgery.
  • Have a tissue sample available from your first breast biopsy.
  • Be able to follow the diet and study rules, including video visits, smart-device apps, home blood sugar and ketone checks, food and exercise logs, and meal preparation. Ketones are made when the body burns fat.

Who can't join

  • Need cancer treatment before surgery, or have surgery planned less than 3 weeks after joining.
  • Cannot follow the diet, have regularly followed a ketogenic diet in the past 3 months, or will join another diet program during the study.
  • Have a breast cancer type such as sarcoma or lymphoma, or have a body mass index (BMI) below 18.5.
  • Have type 1 diabetes, take insulin or diabetes pills that lower blood sugar, or have triglycerides (a blood fat) of 500 or higher.
  • In the past 6 months, have had a heart attack, unstable heart-related chest pain, an abnormal rhythm in the heart’s lower chambers, sudden worsening heart failure, a stroke, or a blood pressure emergency.
  • Have high blood pressure that medicines do not control, or end-stage kidney, liver, or heart disease.
  • Have an inherited problem with how the body processes fats; G6PD deficiency, a low level of an enzyme that protects red blood cells; trouble absorbing nutrients, including after stomach or bowel surgery; or repeated kidney stones or a tendency to get them.
  • Have another illness that the study doctor thinks makes joining unsafe, or a mental health or substance use disorder that would interfere with taking part.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

TX