BREADS: Breast Adjuvant Diet Study

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Carbohydrate restricted dietary intervention; Drug: standard of care aromatase inhibitors

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chris Waring; Phone Number: 424-315-2215; Email: Christopher.Waring@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically confirmed breast cancer
• Planning to start adjuvant hormonal therapy using an aromatase inhibitor or has started adjuvant hormonal therapy using an aromatase inhibitor
• Able to read, write, and understand English
• BMI ≥ 24 kg/m2
• Age ≥ 18 years
• ER and/or PR positive (defined as having ≥ 1% staining for ER and/or PR on IHC)

• Post-menopausal

  • The absence of menstrual cycles in women who have not undergone hysterectomy for at least 12 months preceding cancer diagnosis OR
  • History of a bilateral oophorectomy OR
  • History of a hysterectomy and age >55 OR
  • No menses for <1 year with FSh and estradiol levels in postmenopausal range according to institutional standards
• ECOG Performance Status 0 or 1
• Female
• Written informed consent obtained from subject and ability for subject to comply with requirements of the study

Exclusion Criteria:

• Use of hormonal therapy other than aromatase inhibitors
• History of other malignancy within the past 5 years, except for malignancies with a > 95% likelihood of cure (e.g. thyroid cancer, non-melanoma skin cancer)
• Already consuming a severe carbohydrate restricted (<20 g carbohydrates per day) diet or vegetarian diet
• Currently on or plans to start chemotherapy (HER2/neu targeted therapy okay)
• Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete the study
• Symptomatic metastases (Metastases allowed if asymptomatic)
• Current use of appetite suppressant medications
• Current use of any weight loss medications including herbal weight loss supplements or if patients are enrolled in a diet/weight loss program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary intervention; Carbohydrate restricted dietary intervention (<20 g carbohydrates/day) + standard of care aromatase inhibitors	Other: Carbohydrate restricted dietary intervention; Carbohydrate restricted dietary intervention (<20 g carbohydrates/day); Drug: standard of care aromatase inhibitors; standard of care aromatase inhibitors
Active Comparator: No dietary intervention; Standard of care aromatase inhibitors	Drug: standard of care aromatase inhibitors; standard of care aromatase inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in weight	Difference in change in weight between pre- and post- intervention between carbohydrate restricted and control group	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in serum estradiol	Difference in changes in serum estradiol between pre- and post-intervention between low-carbohydrate group and control group	6 months
Changes in fasting glucose	Difference in changes in fasting glucose between pre- and post-intervention between low-carbohydrate group and control group	6 months
Changes in insulin	Difference in changes in insulin between pre- and post-intervention between low-carbohydrate group and control group	6 months
Changes in HbA1c	Difference in changes in HbA1c between pre- and post-intervention between low-carbohydrate group and control group	6 months
Changes in triglycerides	Difference in changes in triglycerides between pre- and post-intervention between low-carbohydrate group and control group	6 months
Changes in LDL	Difference in changes in LDL between pre- and post-intervention between low-carbohydrate group and control group	6 months
Changes in HDL	Difference in changes in HDL between pre- and post-intervention between low-carbohydrate group and control group	6 months
Changes in cholesterol	Difference in changes in cholesterol between pre- and post-intervention between low-carbohydrate group and control group	6 months

Collaborators and Investigators

• Sponsor: Farin Amersi
• Investigators: Principal Investigator: Farin Amersi, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2020
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: aromatase inhibitor; carbohydrate restricted diet
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; Estrogen Antagonists; Aromatase Inhibitors
• Other Study ID Numbers: IIT2018-21-AMERSI-BREADS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No