BREADS: Breast Adjuvant Diet Study

NCT04189263 | Terminated Phase 2 DMC

• 1 other identifier: IIT2018-21-AMERSI-BREADS
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

aromatase inhibitor; carbohydrate restricted diet

Outcome Measures

Primary Outcomes (1)

• Mean change in weight

  Difference in change in weight between pre- and post- intervention between carbohydrate restricted and control group

  6 months

Secondary Outcomes (8)

• Changes in serum estradiol

  6 months

• Changes in fasting glucose

  6 months

• Changes in insulin

  6 months

• Changes in HbA1c

  6 months

• Changes in triglycerides

  6 months

Study Arms (2)

Dietary intervention

EXPERIMENTAL

Carbohydrate restricted dietary intervention (\<20 g carbohydrates/day) + standard of care aromatase inhibitors

Other: Carbohydrate restricted dietary intervention; Drug: standard of care aromatase inhibitors

No dietary intervention

ACTIVE COMPARATOR

Standard of care aromatase inhibitors

Drug: standard of care aromatase inhibitors

Interventions

Carbohydrate restricted dietary intervention OTHER

Carbohydrate restricted dietary intervention (\<20 g carbohydrates/day)

Dietary intervention

standard of care aromatase inhibitors DRUG

standard of care aromatase inhibitors

Dietary intervention; No dietary intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Farin Amersi: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Farin Amersi, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Surgery

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: February 4, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)