BREADS: Breast Adjuvant Diet Study

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04189263
• Other study ID #: IIT2018-21-AMERSI-BREADS
• Status: Terminated
• Phase: Phase 2
• Start date: February 4, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: April 2023
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Carbohydrate restricted dietary intervention
Carbohydrate restricted dietary intervention (<20 g carbohydrates/day)

Drug:
• standard of care aromatase inhibitors
standard of care aromatase inhibitors

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Farin Amersi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in weight	Difference in change in weight between pre- and post- intervention between carbohydrate restricted and control group	6 months
Secondary	Changes in serum estradiol	Difference in changes in serum estradiol between pre- and post-intervention between low-carbohydrate group and control group	6 months
Secondary	Changes in fasting glucose	Difference in changes in fasting glucose between pre- and post-intervention between low-carbohydrate group and control group	6 months
Secondary	Changes in insulin	Difference in changes in insulin between pre- and post-intervention between low-carbohydrate group and control group	6 months
Secondary	Changes in HbA1c	Difference in changes in HbA1c between pre- and post-intervention between low-carbohydrate group and control group	6 months
Secondary	Changes in triglycerides	Difference in changes in triglycerides between pre- and post-intervention between low-carbohydrate group and control group	6 months
Secondary	Changes in LDL	Difference in changes in LDL between pre- and post-intervention between low-carbohydrate group and control group	6 months
Secondary	Changes in HDL	Difference in changes in HDL between pre- and post-intervention between low-carbohydrate group and control group	6 months
Secondary	Changes in cholesterol	Difference in changes in cholesterol between pre- and post-intervention between low-carbohydrate group and control group	6 months