IIT2018-21-Amersi-BREADS BREADS: Breast Adjuvant Diet Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Mean change in weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Written informed consent obtained from subject and ability for subject to comply with requirements of the study
排除标准
- •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
研究组 & 干预措施
Dietary intervention
Carbohydrate restricted dietary intervention (<20 g carbohydrates/day) + standard of care aromatase inhibitors
干预措施: Carbohydrate restricted dietary intervention (Other)
Dietary intervention
Carbohydrate restricted dietary intervention (<20 g carbohydrates/day) + standard of care aromatase inhibitors
干预措施: standard of care aromatase inhibitors (Drug)
No dietary intervention
Standard of care aromatase inhibitors
干预措施: standard of care aromatase inhibitors (Drug)
结局指标
主要结局
Mean change in weight
时间窗: 6 months
Difference in change in weight between pre- and post- intervention between carbohydrate restricted and control group
次要结局
- Changes in insulin(6 months)
- Changes in HbA1c(6 months)
- Changes in triglycerides(6 months)
- Changes in cholesterol(6 months)
- Changes in serum estradiol(6 months)
- Changes in fasting glucose(6 months)
- Changes in LDL(6 months)
- Changes in HDL(6 months)
研究者
Farin Amersi
Associate Professor, Surgery
Cedars-Sinai Medical Center