Spots Global Cancer Trial Database for NEOBREADS: Neoadjuvant Breast Diet Study
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Trial Identification
Brief Title: NEOBREADS: Neoadjuvant Breast Diet Study
Official Title: IIT2018-25-MITA-NEOBREADS: Neoadjuvant Breast Diet Study
Study ID: NCT03822715
Conditions
Study Description
Brief 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.
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: Monica Mita, MD
Affiliation: Cedars-Sinai Medical Center
Role: PRINCIPAL_INVESTIGATOR
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