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

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

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.

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.

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