BREADS: Breast Adjuvant Diet Study

Sponsor

Farin Amersi (Other)

Overall Status

Recruiting

CT.gov ID

NCT04189263

Collaborator

(none)

Enrollment

Location

Arms

46.9

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Carbohydrate restricted dietary intervention Drug: standard of care aromatase inhibitors	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 4, 2020

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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 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 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
Changes in cholesterol [6 months]
Difference in changes in cholesterol between pre- and post-intervention between low-carbohydrate group and control group

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

Farin Amersi

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Farin Amersi, Associate Professor, Surgery, Cedars-Sinai Medical Center

ClinicalTrials.gov Identifier:

NCT04189263

Other Study ID Numbers:

IIT2018-21-AMERSI-BREADS

First Posted:

Dec 6, 2019

Last Update Posted:

Jul 1, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Farin Amersi, Associate Professor, Surgery, Cedars-Sinai Medical Center

aromatase inhibitor

carbohydrate restricted diet

Additional relevant MeSH terms:

Aromatase Inhibitors

Study Results

No Results Posted as of Jul 1, 2022