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Spots Global Cancer Trial Database for BREADS: Breast Adjuvant Diet Study

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: BREADS: Breast Adjuvant Diet Study

Official Title: IIT2018-21-Amersi-BREADS BREADS: Breast Adjuvant Diet Study

Study ID: NCT04189263

Conditions

Breast Cancer

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Cedars-Sinai Medical Center, Los Angeles, California, United States

Contact Details

Name: Farin Amersi, MD

Affiliation: Cedars-Sinai Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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