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Report for Clinical Trial NCT03962647

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT03962647 Estrogen Receptor-positive Breast Cancer
MeSH:Breast Neoplasms
HPO:Breast carcinoma Neoplasm of the breast

2 Interventions

Name: 2-Week Ketogenic Diet

Description: 2-Week Ketogenic Diet in Combination with Letrozole
Type: Dietary Supplement
Group Labels: 1

2-Week Ketogenic Diet

Name: Letrozole

Description: 2.5 mg taken once daily by mouth
Type: Drug
Group Labels: 1

2-Week Ketogenic Diet


Primary Outcomes

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 diet

Secondary Outcomes

Description: Measured by Ki67

Measure: Measure enhanced inhibition of cancer cell proliferation

Time: After 2 weeks of a ketogenic diet

Description: 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 diet

Description: Waist circumference will be measured

Measure: Measure changes in body composition

Time: After 2 weeks of a ketogenic diet

Description: Weight will be checked

Measure: Measure changes in body composition

Time: After 2 weeks of a ketogenic diet

Description: Height will be checked

Measure: Measure changes in body composition

Time: After 2 weeks of a ketogenic diet

Description: Body mass index will be measured

Measure: Measure changes in body composition

Time: After 2 weeks of a ketogenic diet

Description: Fasting glucose/insulin to measure HOMA-IR

Measure: Measure changes in insulin resistance

Time: After 2 weeks of a ketogenic diet

Description: Rate of ketones production

Measure: Measure effectiveness in inducing a ketogenic state

Time: After 2 weeks of a ketogenic diet

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 P13K

Reduction in measures of insulin/P13K pathway activation. --- P13K ---



HPO Nodes


HPO: