Changes in Intestinal Microbiota in Association With Chemotherapy Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in intestinal microbiota (composition, abundance, and diversity)
研究概览
简要总结
This pilot research trial studies the effects of chemotherapy on intestinal bacteria/organisms (microbiota) in patients newly diagnosed with breast cancer. Change in intestinal microbiota may be associated with weight gain in patients treated with chemotherapy. Weight gain has been also associated with cancer recurrence. Examining the types and quantity of bacterial composition in the stool of breast cancer patients treated with chemotherapy may help determine whether body weight and composition are associated with changes in the intestinal microbiota and allow doctors to plan better treatment to prevent weight gain and possibly disease recurrence.
详细描述
PRIMARY OBJECTIVES:
I. To examine the transitory and longer lasting effects of chemotherapy on the gut microbiota.
SECONDARY OBJECTIVES:
I. To examine the relationship between body composition and gut microbiota before and after chemotherapy.
II. To examine the relationship between blood estrogen levels and gut microbiota before and after chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Newly diagnosed ductal carcinoma in situ or invasive breast cancer (stage I, stage IIA, stage IIB, and stage IIIA breast cancer)
- •A treatment group including surgery followed by standard treatment of adjuvant chemotherapy such as doxorubicin and cyclophosphamide followed by paclitaxel, docetaxel and cyclophosphamide, or a treatment group including neoadjuvant chemotherapy followed by surgery at the Norris or LAC+USC Medical Center
- •Women of child-bearing potential agree to pregnancy test to confirm she is not pregnant
- •Provide informed consent
排除标准
- •Metastatic, recurrent, synchronous or metachronous breast cancer
- •History of other cancers (other than non-melanoma skin cancer)
- •History of autoimmune celiac or inflammatory bowel disease
- •Past bariatric surgery
- •Current or recent pregnancy or nursing (within past 12 months)
- •Past treatment with chemotherapy
- •Recent use (within past month) of more than 3 days of antibiotics use
- •Current use of probiotic supplements
结局指标
主要结局
Change in intestinal microbiota (composition, abundance, and diversity)
时间窗: Baseline to 4 months after final adjuvant (or neoadjuvant) chemotherapy course
Paired sample t-test will be used to determine whether there are significant changes in microbiota diversity (as measured by the number of taxonomic groups) between pre-treatment levels and 1 and 4 months after the final chemotherapy treatment. Mixed-model linear regression on repeated measures will be used to concurrently adjust for physical activity, dietary intakes, and other factors.
次要结局
- Change in body composition based on dual-energy x-ray absorptiometry (DEXA)(Baseline to 4 months after last chemotherapy)
- Baseline estradiol and estrone levels(Baseline)
- Change in estrogen levels(Baseline to up to 4 months after last chemotherapy)