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Comparison of Healthy Diets on Breast Cancer Markers (KetoBreast)

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low carbohydrate diet
Low fat diet
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Neoplasms focused on measuring diet, dietary intervention, carbohydrate restriction, low carbohydrate, fat restriction, low fat, cancer, breast cancer, pre-surgical window, biomarker

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women with biopsy proven breast cancer.

Exclusion Criteria:

-

Sites / Locations

  • The Albert Einstein College of Medicine of Yeshiva University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low carbohydrate diet

Low fat diet

Arm Description

45 subjects will receive a very low carbohydrate diet between a positive breast biopsy and surgical tumor removal

20 subjects will receive a lo fat diet between a positive breast biopsy and surgical tumor removal

Outcomes

Primary Outcome Measures

TUNEL comparison of each dietary intervention at surgical removal to measure change in apoptosis in tumor cells
Ki-67 comparison of each dietary intervention at surgical removal to measure change in proliferation of tumor cells

Secondary Outcome Measures

Full Information

First Posted
April 13, 2016
Last Updated
August 28, 2020
Sponsor
Albert Einstein College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02744079
Brief Title
Comparison of Healthy Diets on Breast Cancer Markers
Acronym
KetoBreast
Official Title
A Pilot Presurgical Trial of Insulin Inhibition by a Ketogenic Diet in Operable Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 22, 2018 (Actual)
Primary Completion Date
August 25, 2020 (Actual)
Study Completion Date
August 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
diet, dietary intervention, carbohydrate restriction, low carbohydrate, fat restriction, low fat, cancer, breast cancer, pre-surgical window, biomarker

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low carbohydrate diet
Arm Type
Active Comparator
Arm Description
45 subjects will receive a very low carbohydrate diet between a positive breast biopsy and surgical tumor removal
Arm Title
Low fat diet
Arm Type
Active Comparator
Arm Description
20 subjects will receive a lo fat diet between a positive breast biopsy and surgical tumor removal
Intervention Type
Behavioral
Intervention Name(s)
Low carbohydrate diet
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Low fat diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
TUNEL comparison of each dietary intervention at surgical removal to measure change in apoptosis in tumor cells
Time Frame
2 years
Title
Ki-67 comparison of each dietary intervention at surgical removal to measure change in proliferation of tumor cells
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with biopsy proven breast cancer. Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene J Fine, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Albert Einstein College of Medicine of Yeshiva University
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22840388
Citation
Fine EJ, Segal-Isaacson CJ, Feinman RD, Herszkopf S, Romano MC, Tomuta N, Bontempo AF, Negassa A, Sparano JA. Targeting insulin inhibition as a metabolic therapy in advanced cancer: a pilot safety and feasibility dietary trial in 10 patients. Nutrition. 2012 Oct;28(10):1028-35. doi: 10.1016/j.nut.2012.05.001. Epub 2012 Jul 26.
Results Reference
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PubMed Identifier
24221746
Citation
Jain R, Strickler HD, Fine E, Sparano JA. Clinical studies examining the impact of obesity on breast cancer risk and prognosis. J Mammary Gland Biol Neoplasia. 2013 Dec;18(3-4):257-66. doi: 10.1007/s10911-013-9307-3. Epub 2013 Nov 13.
Results Reference
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PubMed Identifier
19480693
Citation
Fine EJ, Miller A, Quadros EV, Sequeira JM, Feinman RD. Acetoacetate reduces growth and ATP concentration in cancer cell lines which over-express uncoupling protein 2. Cancer Cell Int. 2009 May 29;9:14. doi: 10.1186/1475-2867-9-14.
Results Reference
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Comparison of Healthy Diets on Breast Cancer Markers

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