Breast Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are willing and able to give their consent to take part in the study
- People who are 18 years of age or older at the time they give consent
- People whose overall physical functioning is rated at a certain level by their doctor (a score of 2 or lower on a standard cancer patient health scale — confirm with trial site)
- People who have gone through menopause at the time they join the study
- People diagnosed with Stage I or II breast cancer (early-stage, not spread to distant parts of the body)
- People who are planned to have breast surgery (either full or partial breast removal) as their first treatment, without needing any chemotherapy, hormone therapy, or other systemic treatment before surgery
- People who have tissue available from their initial breast biopsy, taken as part of their standard care
- People who, in the opinion of the study doctor, are able to follow a ketogenic (very low carbohydrate, high fat) diet and meet study requirements such as attending video appointments, using apps on a smartphone, measuring blood sugar and ketone levels at home, keeping a food and exercise diary, and preparing meals that fit the ketogenic diet
Who may not be able to join:
- People whose doctors have determined they need treatment (such as chemotherapy or hormone therapy) before surgery
- People whose breast surgery is planned to happen in less than 3 weeks from when they would join the study
- People who are unable to follow a ketogenic diet
- People who have been consistently following a ketogenic diet in the past 3 months
- People who are already taking part in another structured diet program during the study period
- People whose breast cancer is a type that does not start in the breast tissue lining, such as sarcoma or lymphoma
- People with a Body Mass Index (a measure of body weight relative to height) below 18.5 (considered underweight)
- People with other health conditions that, in the study doctor's opinion, would prevent them from safely taking part
- People with Type 1 diabetes
- People who use insulin or other diabetes medications taken by mouth to manage blood sugar
- People who have experienced any of the following in the past 6 months: a heart attack, unstable chest pain (angina), a dangerous heart rhythm problem, severe sudden heart failure, a stroke, or a life-threatening spike in blood pressure
- People with high blood pressure that remains uncontrolled even with blood pressure medication
- People with end-stage kidney, liver, or heart disease
- People with inherited genetic conditions that affect how the body processes fats (such as certain enzyme deficiencies — confirm specific conditions with trial site)
- People with a condition called G6PD deficiency, which affects red blood cells
- People with conditions that affect how the body absorbs food, such as inflammatory bowel disease, a history of gastric sleeve surgery, or prior bowel removal surgery
- People with a history of recurring kidney stones or a known predisposition to developing them
- People with very high triglyceride (blood fat) levels of 500 or above
- People with known mental health or substance use conditions that would interfere with taking part in the study
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Saba Shaikh, MD, The University of Texas Health Science Center at San Antonio
Phone: 210-450-5098
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change in tumor immune microenvironment
Can't join this trial?
Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.