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).
Brief Title
Comparison of Healthy Diets on Breast Cancer Markers
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Breast Neoplasms
Eligibility Criteria
Inclusion Criteria:
Women with biopsy proven breast cancer.
Exclusion Criteria:
-
Women with biopsy proven breast cancer.
Exclusion Criteria:
-
Inclusion Criteria
Inclusion Criteria:
Women with biopsy proven breast cancer.
Women with biopsy proven breast cancer.
Gender
Female
Gender Based
false
Keywords
diet
dietary intervention
carbohydrate restriction
low carbohydrate
fat restriction
low fat
cancer
breast cancer
pre-surgical window
biomarker
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
21 Years
NCT Id
NCT02744079
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2016-6346
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Pilot Presurgical Trial of Insulin Inhibition by a Ketogenic Diet in Operable Breast Cancer
Primary Outcomes
Outcome Measure
TUNEL comparison of each dietary intervention at surgical removal to measure change in apoptosis in tumor cells
Outcome Time Frame
2 years
Outcome Measure
Ki-67 comparison of each dietary intervention at surgical removal to measure change in proliferation of tumor cells
Outcome Time Frame
2 years
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
21
Investigators
Investigator Type
Principal Investigator
Investigator Name
Eugene Fine
Investigator Email
eugene.fine@einsteinmed.org
Investigator Phone
718-904-2639