BREADS: Breast Adjuvant Diet Study

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: standard of care aromatase inhibitors; Other: Carbohydrate restricted dietary intervention

• Registration Number: NCT04189263
• Lead Sponsor: Farin Amersi

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

Not available

Study Timeline

• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-06
• Study Start: 2020-02-04
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-16
• Last Update Posted: 2023-04-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No dietary intervention	standard of care aromatase inhibitors	Standard of care aromatase inhibitors
Dietary intervention	Carbohydrate restricted dietary intervention	Carbohydrate restricted dietary intervention (\<20 g carbohydrates/day) + standard of care aromatase inhibitors
Dietary intervention	standard of care aromatase inhibitors	Carbohydrate restricted dietary intervention (\<20 g carbohydrates/day) + standard of care aromatase inhibitors

Primary Outcome Measures

Name	Time	Method
Mean change in weight	6 months	Difference in change in weight between pre- and post- intervention between carbohydrate restricted and control group

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States