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Low participant compliance, slow recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary intervention | Experimental | Carbohydrate restricted dietary intervention (<20 g carbohydrates/day) + standard of care aromatase inhibitors |
|
| No dietary intervention | Active Comparator | Standard of care aromatase inhibitors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbohydrate restricted dietary intervention | Other | Carbohydrate restricted dietary intervention (<20 g carbohydrates/day) |
|
| 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 |
| 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 |
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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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Farin Amersi, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| standard of care aromatase inhibitors | Drug | standard of care aromatase inhibitors |
|
| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |