MedTrace Logo

BREADS: Breast Adjuvant Diet Study

NCT04189263 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-04-19

No results posted yet for this study

Summary

This is a randomized controlled trial of a 6-month extreme carbohydrate restricted diet (20 grams total carbs/day) via phone counseling with dietitian plus aromatase inhibitor therapy vs. 6-month control with aromatase inhibitor therapy alone. Visits will occur at screening, 3 months, and 6 months. Anthropomorphic measurements (such as heart rate, weight, and body measurement) and questionnaires will be taken at all three visits. After screening, patients will be randomized to receive the carbohydrate restricted diet coaching immediately (Arm A) or to a control group (Arm B). Patients randomized to Arm A will receive weekly calls for the first 3 months of the intervention, then biweekly calls for the last 3 months of the intervention from the study dietitian. Total duration of the study is expected to be 3 years, though each patient's participation will be approximately 6 months.

Conditions

Interventions

OTHER

Carbohydrate restricted dietary intervention

Carbohydrate restricted dietary intervention (\<20 g carbohydrates/day)

DRUG

standard of care aromatase inhibitors

standard of care aromatase inhibitors

Sponsors & Collaborators

  • Farin Amersi

    lead OTHER

Principal Investigators

  • Farin Amersi, MD · Cedars-Sinai Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-04
Primary Completion
2023-03-30
Completion
2023-03-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04189263 on ClinicalTrials.gov