Study on Skin Microbiome of HFS

• Conditions: Microbiota
• Interventions: Drug: Capecitabine 150Mg Oral Tablet

• Registration Number: NCT04132713
• Lead Sponsor: First Affiliated Hospital of Harbin Medical University

Brief Summary

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

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

Study Timeline

• Status Verified: 2019-09
• Study Start: 2019-09-10
• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-18
• Last Update Submitted: 2019-10-18
• Study First Posted: 2019-10-21
• Last Update Posted: 2019-10-21
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Disease group	Capecitabine 150Mg Oral Tablet	30 patients with advanced breast cancer developed hand-foot syndrome after capecitabine administration

Primary Outcome Measures

Name	Time	Method
Transcriptional changes in skin microbiota	baseline,1 day, 21 days,42 days,65 days,85 days,106 days,127 days	The microbiota measured by 16S rRNA gene

Trial Locations

Locations (1)

First affiliated hospital of Harbin medical university; 🇨🇳 Harbin, Heilongjiang, China