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NEOBREADS: Neoadjuvant Breast Diet Study

NCT03822715 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-09-01

No results posted yet for this study

Summary

This is a feasibility trial of a 6-month extreme carbohydrate restricted diet (20 grams total carbs/day) via counseling with dietitian plus aromatase inhibitor therapy. Visits will occur at screening, mid-study, and pre-surgery. Anthropomorphic measurements, and patient reported outcomes (PROs) will be taken at all three visits. Patients will speak with a dietitian at their monthly standard of care visits, and will receive weekly calls for the first 4 weeks of the intervention. All subjects will receive surgery after approximately 6 months of intervention. Total duration of the study is expected to be 2 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

  • Cedars-Sinai Medical Center

    collaborator OTHER

  • Monica Mita

    lead OTHER

Principal Investigators

  • Monica Mita, MD · Cedars-Sinai Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-21
Primary Completion
2021-08-17
Completion
2021-08-17

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 NCT03822715 on ClinicalTrials.gov