Clinical trial NCT02744079: Comparison of Healthy Diets on Breast Cancer Markers
Official title: A Pilot Presurgical Trial of Insulin Inhibition by a Ketogenic Diet in Operable Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: diet
dietary intervention
carbohydrate restriction
low carbohydrate
fat restriction
low fat
cancer
breast cancer
pre-surgical window
biomarker
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 11
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

Women with biopsy proven breast cancer.

Exclusion Criteria:

-

Primary outcomes:
measure: TUNEL comparison of each dietary intervention at surgical removal to measure change in apoptosis in tumor cells
timeFrame: 2 years
measure: Ki-67 comparison of each dietary intervention at surgical removal to measure change in proliferation of tumor cells
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: The Albert Einstein College of Medicine of Yeshiva University
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Eugene J Fine, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.