Study on Skin Microbiome of HFS

Microbiota Clinical Trial

Official title:

Study on Skin Microbiota of Hand Foot Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04132713
• Other study ID #: Yunwei Wei 2019-09-12
• Status: Recruiting
• Start date: September 10, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: September 2019
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: Yunwei Wei, doctor
• Phone: +86-0451-85553099
• Email: hydwyw11[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Microbiota

Intervention

Drug:
• Capecitabine 150Mg Oral Tablet
Advanced breast cancer patients with first-line medication

Locations

Country	Name	City	State
China	First affiliated hospital of Harbin medical university	Harbin	Heilongjiang

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University	Sponsor GmbH

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Review. — View Citation

Roth RR, James WD. Microbiology of the skin: resident flora, ecology, infection. J Am Acad Dermatol. 1989 Mar;20(3):367-90. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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