Comparison of Healthy Diets on Breast Cancer Markers



Status:Recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:6/29/2018
Start Date:June 22, 2018
End Date:September 2020
Contact:Eugene J Fine, MD
Email:eugene.fine@einstein.yu.edu
Phone:718-904-2639

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

Women post breast mass biopsy with ER+ cancer will be randomized to two diets--45 of them to
a ketogenic insulin inhibiting diet, 20 to a low fat diet simulating their existing diet, but
with added 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).

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.

Inclusion Criteria:

Women with biopsy proven estrogen receptor positive breast cancer.

Exclusion Criteria:
We found this trial at
1
site
Bronx, New York 10467
Principal Investigator: Eugene Fine, MD
Phone: 718-904-2639
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Bronx, NY
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