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A 2-Week Ketogenic Diet in Combination With Letrozole to Modulate PI3K Signaling in ER+ Breast Cancer

Estrogen Receptor-positive Breast Cancer Clinical Trial

Official title:
A Pilot and Feasibility Neoadjuvant Study of a 2-Week Ketogenic Diet in Combination With Letrozole to Modulate PI3K Signaling in ER+ Breast Cancer

Clinical Trial Summary

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.

Clinical Trial Description

Primary Objective: • To evaluate the feasibility and tolerability of a 2 week ketogenic diet in combination with endocrine therapy prior to surgery for early stage ER+ breast cancer. Secondary Objectives - To determine whether endocrine therapy in combination with a dietary intervention to reduce insulin pathway signaling results in enhanced inhibition of cancer cell proliferation (measured byKi67) - To determine the effectiveness of 2 weeks of a ketogenic diet to reduce measures of insulin/PI3Kpathway activation in breast tumors - To measure changes in weight and body composition after 2 weeks of a ketogenic diet - To measure changes in insulin resistance after 2 weeks of a ketogenic diet - To measure the effectiveness of a ketogenic diet in combination with endocrine therapy to induce and maintain a ketogenic state. Outline: Participants will have baseline metabolic parameters measured and will begin a 2-week diet consisting of meal replacement shakes to induce a ketogenic state. Patients will also receive letrozole 2.5 mg daily. At the end of 2 weeks, metabolic parameters will again be measured and patients will proceed with surgical treatment of their breast cancer. A tumor biopsy from the surgical specimen will be obtained to measure cell proliferation compared with the pre-treatment diagnostic biopsy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03962647
Study type Interventional
Source Vanderbilt-Ingram Cancer Center
Contact
Status Active, not recruiting
Phase Early Phase 1
Start date July 8, 2019
Completion date May 2025
View Details
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