Study on Skin Microbiota of Hand Foot Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Transcriptional changes in skin microbiota
研究概览
简要总结
To skin microecology and breast cancer chemotherapy drug therapy as the breakthrough point, disease prevention and treatment of breast cancer in China, the important scientific problems in basic research, through in-depth study of skin micro ecological changes in advanced breast cancer chemotherapy and its regulatory mechanism, clear skin flora occurred after application of capecitabine and the influence and mechanism of the immune response;Finding markers for the treatment and prognosis of related diseases;Identify and isolate key strains and/or metabolites, and conduct intervention studies to reveal new mechanisms of skin microflora homeostasis and toxic and side effects of breast cancer chemotherapy.
详细描述
To skin microecology and breast cancer chemotherapy drug therapy as the breakthrough point, disease prevention and treatment of breast cancer in China, the important scientific problems in basic research, through in-depth study of skin micro ecological changes in advanced breast cancer chemotherapy and its regulatory mechanism, clear skin flora occurred after application of capecitabine and the influence and mechanism of the immune response;Finding markers for the treatment and prognosis of related diseases;Identify and isolate key strains and/or metabolites, and conduct intervention studies to reveal new mechanisms of skin microflora homeostasis and toxic and side effects of breast cancer chemotherapy
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age: 18-65 years old
- •advanced breast cancer patients
- •healthy volunteers
排除标准
- •previous skin disease history, or other skin disease activity at present
- •various antibiotics, prebiotics, probiotics or lactic acid products used within three months;
- •having a history of alcoholism for more than 2 years and smoking for years;
- •pregnancy or lactation;
- •have oral, respiratory and gastrointestinal diseases;
- •other metabolic diseases, such as obesity, hypertension, diabetes, stones, and liver diseases;
- •other autoimmune diseases, such as rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel disease;
- •history of gastrointestinal surgery;
- •family genetic history, history of mental illness, etc.;
- •the subject is participating in other research projects;
- •other reasons are not considered suitable for continued clinical trials.
研究组 & 干预措施
Disease group
30 patients with advanced breast cancer developed hand-foot syndrome after capecitabine administration
干预措施: Capecitabine 150Mg Oral Tablet (Drug)
结局指标
主要结局
Transcriptional changes in skin microbiota
时间窗: baseline,1 day, 21 days,42 days,65 days,85 days,106 days,127 days
The microbiota measured by 16S rRNA gene
次要结局
未报告次要终点