Clinical trial NCT04132713: Study on Skin Microbiome of HFS
Official title: Study on Skin Microbiota of Hand Foot Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microbiota
Keywords: skin microbiota
16S rRNA gene
hand foot sysdom
breast cancer chemotherapy
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
Collaborators: name: Sponsor GmbH
First posted: 2019-10-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients were included according to the inclusion and exclusion criteria

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

Eligibility criteria: 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.

Primary outcomes:
measure: Transcriptional changes in skin microbiota
timeFrame: baseline,1 day, 21 days,42 days,65 days,85 days,106 days,127 days
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: First affiliated hospital of Harbin medical university
state: Heilongjiang
Study officials:
References:
citation: Weese JS. The canine and feline skin microbiome in health and disease. Vet Dermatol. 2013 Feb;24(1):137-45.e31. doi: 10.1111/j.1365-3164.2012.01076.x.
citation: Kong HH, Segre JA. Skin microbiome: looking back to move forward. J Invest Dermatol. 2012 Mar;132(3 Pt 2):933-9. doi: 10.1038/jid.2011.417. Epub 2011 Dec 22.
citation: Roth RR, James WD. Microbiology of the skin: resident flora, ecology, infection. J Am Acad Dermatol. 1989 Mar;20(3):367-90. doi: 10.1016/s0190-9622(89)70048-7.