Comparison of Healthy Diets on Breast Cancer Markers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Behavioral: Low carbohydrate diet
* Behavioral: Low fat diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with biopsy proven breast cancer. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low carbohydrate diet<br>45 subjects will receive a very low carbohydrate diet between a positive breast biopsy and surgical tumor removal | Behavioral: Low carbohydrate diet<br>* 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<br>|
| Active Comparator: Low fat diet<br>20 subjects will receive a lo fat diet between a positive breast biopsy and surgical tumor removal | Behavioral: Low fat diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet, dietary intervention, carbohydrate restriction, low carbohydrate, fat restriction, low fat, cancer, breast cancer, pre-surgical window, biomarker