Study on Skin Microbiome of HFS

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Study on Skin Microbiota of Hand Foot Syndrome

Conditions
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Microbiota

Intervention / Treatment
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* Drug: Capecitabine 150Mg Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: 18-65 years old advanced breast cancer patients healthy volunteers Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>20 healthy volunteers were included in the healthy control group | |
| Disease group<br>30 patients with advanced breast cancer developed hand-foot syndrome after capecitabine administration | Drug: Capecitabine 150Mg Oral Tablet<br>* Advanced breast cancer patients with first-line medication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcriptional changes in skin microbiota | The microbiota measured by 16S rRNA gene | baseline,1 day, 21 days,42 days,65 days,85 days,106 days,127 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin microbiota, 16S rRNA gene, hand foot sysdom, breast cancer chemotherapy