This is a neoadjuvant study to determine the feasibility and tolerability of 2 weeks of a very low carbohydrate ketogenic diet in combination with letrozole for patients with early stage operable ER+disease.
Name: 2-Week Ketogenic Diet
Description: 2-Week Ketogenic Diet in Combination with LetrozoleType: Dietary Supplement2-Week Ketogenic Diet
Name: Letrozole
Description: 2.5 mg taken once daily by mouthType: Drug2-Week Ketogenic Diet
Description: The number of patients who complete the dietary intervention, as well as the reasons for early discontinuation and any adverse events will be reported. The number of of cases where pre- and post-treatment samples could be obtained and successfully analyzed for Ki67 and insulin signaling will also be reported.
Measure: Patients who complete the dietary intervention Time: After 2 weeks of a ketogenic dietDescription: Measured by Ki67
Measure: Measure enhanced inhibition of cancer cell proliferation Time: After 2 weeks of a ketogenic dietDescription: Marks of insulin receptor/PI3K pathway activation in tumors
Measure: Reduction in measures of insulin/P13K pathway activation Time: After 2 weeks of a ketogenic dietDescription: Waist circumference will be measured
Measure: Measure changes in body composition Time: After 2 weeks of a ketogenic dietDescription: Weight will be checked
Measure: Measure changes in body composition Time: After 2 weeks of a ketogenic dietDescription: Height will be checked
Measure: Measure changes in body composition Time: After 2 weeks of a ketogenic dietDescription: Body mass index will be measured
Measure: Measure changes in body composition Time: After 2 weeks of a ketogenic dietDescription: Fasting glucose/insulin to measure HOMA-IR
Measure: Measure changes in insulin resistance Time: After 2 weeks of a ketogenic dietDescription: Rate of ketones production
Measure: Measure effectiveness in inducing a ketogenic state Time: After 2 weeks of a ketogenic dietSingle Group Assignment
There is one SNP
Reduction in measures of insulin/P13K pathway activation. --- P13K ---