BREADS: Breast Adjuvant Diet Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Carbohydrate restricted dietary intervention
* Drug: standard of care aromatase inhibitors


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aromatase inhibitor, carbohydrate restricted diet