Clinical Trials /

BREADS: Breast Adjuvant Diet Study

NCT04189263

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: IIT2018-21-AMERSI-BREADS
  • NCT ID: NCT04189263

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
standard of care aromatase inhibitorsDietary intervention

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Dietary interventionExperimentalCarbohydrate restricted dietary intervention (<20 g carbohydrates/day) + standard of care aromatase inhibitors
  • standard of care aromatase inhibitors
No dietary interventionActive ComparatorStandard of care aromatase inhibitors
  • standard of care aromatase inhibitors

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed breast cancer

          -  Planning to start adjuvant hormonal therapy using an aromatase inhibitor

          -  Able to read, write, and understand English

          -  BMI ≥ 24 kg/m2

          -  Age ≥ 18 years

          -  If Her-2 positive, completed Herceptin therapy prior to enrollment

          -  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

          -  Plans to start chemotherapy or HER2 targeted therapy

          -  Medical comorbidities that in the opinion of the investigator limits the patient's
             ability to complete the study

          -  Symptomatic metastases (Metastases allowed if asymptomatic)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Mean change in weight
Time Frame:6 months
Safety Issue:
Description:Difference in change in weight between pre- and post- intervention between carbohydrate restricted and control group

Secondary Outcome Measures

Measure:Changes in serum estradiol
Time Frame:6 months
Safety Issue:
Description:Difference in changes in serum estradiol between pre- and post-intervention between low-carbohydrate group and control group
Measure:Changes in fasting glucose
Time Frame:6 months
Safety Issue:
Description:Difference in changes in fasting glucose between pre- and post-intervention between low-carbohydrate group and control group
Measure:Changes in insulin
Time Frame:6 months
Safety Issue:
Description:Difference in changes in insulin between pre- and post-intervention between low-carbohydrate group and control group
Measure:Changes in HbA1c
Time Frame:6 months
Safety Issue:
Description:Difference in changes in HbA1c between pre- and post-intervention between low-carbohydrate group and control group
Measure:Changes in triglycerides
Time Frame:6 months
Safety Issue:
Description:Difference in changes in triglycerides between pre- and post-intervention between low-carbohydrate group and control group
Measure:Changes in LDL
Time Frame:6 months
Safety Issue:
Description:Difference in changes in LDL between pre- and post-intervention between low-carbohydrate group and control group
Measure:Changes in HDL
Time Frame:6 months
Safety Issue:
Description:Difference in changes in HDL between pre- and post-intervention between low-carbohydrate group and control group
Measure:Changes in cholesterol
Time Frame:6 months
Safety Issue:
Description:Difference in changes in cholesterol between pre- and post-intervention between low-carbohydrate group and control group

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Farin Amersi

Trial Keywords

  • aromatase inhibitor
  • carbohydrate restricted diet

Last Updated

February 8, 2020