Impact of Ketogenic Diet on Tumor Microenvironment in Patients With Breast Cancer
Purpose
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.
Condition
- Breast Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Prospective, single-institution, window study
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Ketogenic Diet Treatment arm |
Patients with early-stage breast cancer will adhere to a ketogenic diet for 3 weeks prior to surgery. |
|
Recruiting Locations
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center at San Antonio
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.