Breast Neoplasms
Conditions
Keywords
diet, dietary intervention, carbohydrate restriction, low carbohydrate, fat restriction, low fat, cancer, breast cancer, pre-surgical window, biomarker
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).
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.
Interventions
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
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.
Sponsors
Study design
Eligibility
Inclusion criteria
Women with biopsy proven breast cancer.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States