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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Low carbohydrate diet |
45 subjects will receive a very low carbohydrate diet between a 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 |
|
More Details
- Status
- Completed
- Sponsor
- Albert Einstein College of Medicine
Study Contact
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.