IIT2018-25-MITA-NEOBREADS: Neoadjuvant Breast Diet Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Diet adherence
研究概览
简要总结
This is a feasibility trial of a 6-month extreme carbohydrate restricted diet (20 grams total carbs/day) via counseling with dietitian plus aromatase inhibitor therapy. Visits will occur at screening, mid-study, and pre-surgery. Anthropomorphic measurements, and patient reported outcomes (PROs) will be taken at all three visits. Patients will speak with a dietitian at their monthly standard of care visits, and will receive weekly calls for the first 4 weeks of the intervention. All subjects will receive surgery after approximately 6 months of intervention. Total duration of the study is expected to be 2 years, though each patient's participation will be approximately 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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; clinical T2-T4c, any N, M0 invasive breast cancer by AJCC 7th edition clinical staging, with goal being surgery to complete excision of tumor in the breast and lymph node. Primary tumor must be palpable, largest diameter >2.0 cm by physical examination or by radiological assessment.
- •ER/PR+; defined as either ER and/or PR +, 1+ in 10% of cells
- •HER2 Negative; HER2 negative is defined by the following criteria:
- •0 or 1+ by IHC and ISH not done
- •0 or 1+ by IHC or ISH ratio (HER2 gene copy/chromosome 17) < 2
- •2+ by IHC and ISH ratio (HER2 gene copy/chromosome 17) < 2
- •Ability to read, write, and understand English
- •BMI >24 kg/m2
- •ECOG performance status 0-2
- •Planning to receive neoadjuvant aromatase inhibitor therapy
- •Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- •Age > 18 years
排除标准
- •Already consuming a severely carbohydrate-restricted (i.e. <20g total carbohydrates per day) or vegetarian diet
- •Medical comorbidities that in the opinion of the investigator limits the patient's ability to complete this study
- •Candidate for chemotherapy or HER2 directed therapy
- •Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy, or investigational agent prior to study entry (initiation of AI within 30 days of diet initiation acceptable)
- •Loss of >10% of body weight within the previous 6 months
- •Clinical or radiographic evidence of metastatic disease.
- •Current use of weight loss medications including herbal weight loss supplements or 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)
结局指标
主要结局
Diet adherence
时间窗: 6 months
Proportion of patients able to consistently adhere to the low carbohydrate diet in combination with AIs during neo-adjuvant treatment. The patient will be considered adherent for each food diary if \<20% of calories were obtained from carbohydrates. This will be approximately 80 grams of carbohydrates but will vary depending on total caloric intake. A patient will be considered adherent to the diet overall if they meet the adherence cutoff at least 75% of the time (i.e. in at least 75% of food diaries for a single patient \<20% of calories were obtained from carbohydrates).
次要结局
- Change in tumor size(6 months)
- Mean change in Ki67(6 months)
- Mean change in HbA1c(6 months)
- Mean change in total cholesterol(6 months)
- Mean change in weight(6 months)
- Mean change in insulin(6 months)
- Mean change in triglycerides(6 months)
- Mean change in LDL cholesterol(6 months)
- Mean change in HDL cholesterol(6 months)
研究者
Monica Mita
Professor, Medicine
Cedars-Sinai Medical Center