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Comparison of Healthy Diets on Breast Cancer Markers (KetoBreast)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02744079
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Eugene Fine, Albert Einstein College of Medicine

Tracking Information
First Submitted Date  ICMJE April 13, 2016
First Posted Date  ICMJE April 20, 2016
Last Update Posted Date August 31, 2020
Actual Study Start Date  ICMJE June 22, 2018
Actual Primary Completion Date August 25, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
  • TUNEL comparison of each dietary intervention at surgical removal to measure change in apoptosis in tumor cells [ Time Frame: 2 years ]
  • Ki-67 comparison of each dietary intervention at surgical removal to measure change in proliferation of tumor cells [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Healthy Diets on Breast Cancer Markers
Official Title  ICMJE A Pilot Presurgical Trial of Insulin Inhibition by a Ketogenic Diet in Operable Breast Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Behavioral: Low carbohydrate diet
    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
  • Behavioral: Low fat diet
    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.
Study Arms  ICMJE
  • Active Comparator: Low carbohydrate diet
    45 subjects will receive a very low carbohydrate diet between a positive breast biopsy and surgical tumor removal
    Intervention: Behavioral: Low carbohydrate diet
  • Active Comparator: Low fat diet
    20 subjects will receive a lo fat diet between a positive breast biopsy and surgical tumor removal
    Intervention: Behavioral: Low fat diet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2020)
11
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2016)
65
Actual Study Completion Date  ICMJE August 25, 2020
Actual Primary Completion Date August 25, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Women with biopsy proven breast cancer.

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02744079
Other Study ID Numbers  ICMJE 2016-6346
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eugene Fine, Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eugene J Fine, MD Albert Einstein College of Medicine
PRS Account Albert Einstein College of Medicine
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP