Study on Skin Microbiome of HFS

Harbin Medical University

Status: Unknown

Conditions: Microbiota

Treatments: Drug: Capecitabine 150Mg Oral Tablet

Study type: Observational

Funder types: Other

Identifiers

NCT04132713

Yunwei Wei 2019-09-12

Details and patient eligibility

About

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.

Full description

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

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups

Control group

Description:

20 healthy volunteers were included in the healthy control group

Disease group

Description:

30 patients with advanced breast cancer developed hand-foot syndrome after capecitabine administration

Treatment:

Drug: Capecitabine 150Mg Oral Tablet