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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

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).

Condition or disease Intervention/treatment Phase
Breast Neoplasms Behavioral: Low carbohydrate diet Behavioral: Low fat diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Presurgical Trial of Insulin Inhibition by a Ketogenic Diet in Operable Breast Cancer
Actual Study Start Date : June 22, 2018
Actual Primary Completion Date : August 25, 2020
Actual Study Completion Date : August 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Low carbohydrate diet
45 subjects will receive a very low carbohydrate diet between a positive breast biopsy and surgical tumor removal
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

Active Comparator: Low fat diet
20 subjects will receive a lo fat diet between a 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.




Primary Outcome Measures :
  1. TUNEL comparison of each dietary intervention at surgical removal to measure change in apoptosis in tumor cells [ Time Frame: 2 years ]
  2. Ki-67 comparison of each dietary intervention at surgical removal to measure change in proliferation of tumor cells [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Women with biopsy proven breast cancer.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744079


Locations
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United States, New York
The Albert Einstein College of Medicine of Yeshiva University
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
Investigators
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Principal Investigator: Eugene J Fine, MD Albert Einstein College of Medicine
Publications:
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Responsible Party: Eugene Fine, Professor of Radiology, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT02744079    
Other Study ID Numbers: 2016-6346
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eugene Fine, Albert Einstein College of Medicine:
diet
dietary intervention
carbohydrate restriction
low carbohydrate
fat restriction
low fat
cancer
breast cancer
pre-surgical window
biomarker
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases