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.
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
Interventions
Drug | Synonyms | Arms |
---|
standard of care aromatase inhibitors | | Dietary 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
Name | Type | Description | Interventions |
---|
Dietary intervention | Experimental | Carbohydrate restricted dietary intervention (<20 g carbohydrates/day) + standard of care aromatase inhibitors | - standard of care aromatase inhibitors
|
No dietary intervention | Active Comparator | Standard of care aromatase inhibitors | - standard of care aromatase inhibitors
|
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed breast cancer
- 4.1.2 Planning to start adjuvant hormonal therapy using an aromatase inhibitor or has
started adjuvant hormonal therapy using an aromatase inhibitor within 14 days of
randomization.
- 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)
- 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
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
July 15, 2021