Comparison of Healthy Diets on Breast Cancer Markers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-22

Study Completion Date

2020-08-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Use of Metformin in Early Breast Cancer Patients Pre-Surgery

NCT01302002

Breast Cancer

WITHDRAWN EARLY_PHASE1

Enabling the Study of Metabolism in Breast Cancer Through Collection of Fresh-tissue Biopsies

NCT03880097

Breast Cancer

NOT_YET_RECRUITING

Diabetes Care for Breast Cancer Patients

NCT05565534

Breast Cancer PreDiabetes Type 2 Diabetes

COMPLETED NA

Study of Biomarkers Associated With Fatigue in Patients With Early-Stage Breast Cancer Treated With Metformin or Placebo on NCIC-CTG-MA.32

NCT01286233

Breast Cancer Depression Fatigue +1 more

UNKNOWN

Pilot Study To Investigate Targetable Metabolic Pathways Sustaining Triple Negative Breast Cancer

NCT03457779

Triple Negative Breast Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low carbohydrate diet

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

Group Type ACTIVE_COMPARATOR

Low carbohydrate diet

Intervention Type BEHAVIORAL

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 fat diet

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

Group Type ACTIVE_COMPARATOR

Low fat diet

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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.

Intervention Type BEHAVIORAL