NCT02744079

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
2.2 years until next milestone

Study Start

First participant enrolled

June 22, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2020

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

2.2 years

First QC Date

April 13, 2016

Last Update Submit

August 28, 2020

Conditions

Breast Neoplasms

Keywords

dietdietary interventioncarbohydrate restrictionlow carbohydratefat restrictionlow fatcancerbreast cancerpre-surgical windowbiomarker

Outcome Measures

Primary Outcomes (2)

  • TUNEL comparison of each dietary intervention at surgical removal to measure change in apoptosis in tumor cells

    2 years

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

    2 years

Study Arms (2)

Low carbohydrate diet

ACTIVE COMPARATOR

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

Behavioral: Low carbohydrate diet

Low fat diet

ACTIVE COMPARATOR

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

Behavioral: Low fat diet

Interventions

Low carbohydrate dietBEHAVIORAL

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

Low carbohydrate diet
Low fat dietBEHAVIORAL

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.

Low fat diet

Eligibility Criteria

Age21 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with biopsy proven breast cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Albert Einstein College of Medicine of Yeshiva University

The Bronx, New York, 10461, United States

Location

Related Publications (3)

  • 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.

    PMID: 22840388BACKGROUND

  • 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.

    PMID: 24221746BACKGROUND

  • 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.

    PMID: 19480693BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Interventions

Diet, Carbohydrate-RestrictedDiet, Fat-Restricted

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Eugene J Fine, MD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiology

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 20, 2016

Study Start

June 22, 2018

Primary Completion

August 25, 2020

Study Completion

August 25, 2020

Last Updated

August 31, 2020

Record last verified: 2020-08

Locations

US(1)