KetoBreast: Comparison of Healthy Diets on Breast Cancer Markers

Sponsor

Albert Einstein College of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02744079

Collaborator

(none)

Enrollment

Location

Arms

26.1

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Women post breast mass biopsy with ER+or ER- cancer will be randomized to two diets--goal of 45 of them to a ketogenic insulin inhibiting diet, 20 to a low fat diet with whole grains and fruits and vegetables. The initial biopsy will be evaluated along with the surgical specimen pathology to compare changes in biomarkers, particularly of proliferation (Ki-67) and apoptosis (TUNEL).

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Behavioral: Low carbohydrate diet Behavioral: Low fat diet	N/A

Detailed Description

A healthy diet has been defined in various ways. The investigators wish to compare the effects of two diets on ER positive breast cancer tissues. The diets will be administered between the time of diagnosis and the time of surgical removal. Both diets have been proposed as healthy, but differ in their composition. One constitutes a low fat diet with extra fiber, fruits and vegetable servings, while the other comprises a diet low in carbohydrate content, aiming to lower insulin secretion. Patients will be randomized to each group, with 20 assigned to the low fat arm and 45 to the low carbohydrate arm.

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

A Pilot Presurgical Trial of Insulin Inhibition by a Ketogenic Diet in Operable Breast Cancer

Actual Study Start Date :

Jun 22, 2018

Actual Primary Completion Date :

Aug 25, 2020

Actual Study Completion Date :

Aug 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Low carbohydrate diet 45 subjects will receive a very low carbohydrate diet between a positive breast biopsy and surgical tumor removal	Behavioral: Low carbohydrate diet 45 subjects will be randomized to a dietary arm consisting of a complete, prepared very low carbohydrate diet, delivered to their homes, for the interval between positive breast biopsy and surgical tumor removal
Active Comparator: Low fat diet 20 subjects will receive a lo fat diet between a positive breast biopsy and surgical tumor removal	Behavioral: Low fat diet 20 subjects will be randomized to a dietary arm consisting of a complete, prepared low fat diet, delivered to their homes, for the interval between positive breast biopsy and surgical tumor removal.

Arm

Intervention/Treatment

Active Comparator: Low carbohydrate diet

45 subjects will receive a very low carbohydrate diet between a positive breast biopsy and surgical tumor removal

Behavioral: Low carbohydrate diet

45 subjects will be randomized to a dietary arm consisting of a complete, prepared very low carbohydrate diet, delivered to their homes, for the interval between positive breast biopsy and surgical tumor removal

Active Comparator: Low fat diet

20 subjects will receive a lo fat diet between a positive breast biopsy and surgical tumor removal

Behavioral: Low fat diet

20 subjects will be randomized to a dietary arm consisting of a complete, prepared low fat diet, delivered to their homes, for the interval between positive breast biopsy and surgical tumor removal.

Outcome Measures

Primary Outcome Measures

TUNEL comparison of each dietary intervention at surgical removal to measure change in apoptosis in tumor cells [2 years]
Ki-67 comparison of each dietary intervention at surgical removal to measure change in proliferation of tumor cells [2 years]