Study on Skin Microbiome of HFS

Overview

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 Title of Study: “Study on Skin Microbiota of Hand Foot Syndrome”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: October 15, 2020

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

Interventions

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

Arms, Groups and Cohorts

  • Control group
    • 20 healthy volunteers were included in the healthy control group
  • Disease group
    • 30 patients with advanced breast cancer developed hand-foot syndrome after capecitabine administration

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • First Affiliated Hospital of Harbin Medical University
  • Collaborator
    • Sponsor GmbH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Yunwei Wei, doctor, +86-0451-85553099, hydwyw11@hotmail.com

References

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.

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.

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.

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