Comparison of Healthy Diets on Breast Cancer Markers

Purpose

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

  • Breast Neoplasms

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

Women with biopsy proven breast cancer.

Exclusion Criteria

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

The Albert Einstein College of Medicine of Yeshiva University
Bronx, New York 10461
Contact:
Eugene J Fine, MD
718-904-2639
eugene.fine@einstein.yu.edu

More Details

Status
Recruiting
Sponsor
Albert Einstein College of Medicine

Study Contact

Eugene J Fine, MD
718-904-2639
eugene.fine@einstein.yu.edu

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.