Study on Skin Microbiome of HFS

Study on Skin Microbiota of Hand Foot Syndrome

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 Overview

• Status: Unknown
• Conditions: Microbiota
• Intervention / Treatment: Drug: Capecitabine 150Mg Oral Tablet

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Yunwei Wei, doctor; Phone Number: +86-0451-85553099; Email: hydwyw11@hotmail.com
• Study Contact Backup: Name: xin Wu; Phone Number: +86-0451-85553099; Email: wuxin199509@163.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • Recruiting
      • First Affiliated Hospital of Harbin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

All patients were included according to the inclusion and exclusion criteria

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: Capecitabine 150Mg Oral Tablet; Advanced breast cancer patients with first-line medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Harbin Medical University
• Collaborators: Sponsor GmbH

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Anticipated): October 15, 2020
• Study Completion (Anticipated): October 15, 2020

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 18, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 21, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: 16S rRNA gene; breast cancer chemotherapy; skin microbiota; hand foot sysdom
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine
• Other Study ID Numbers: Yunwei Wei 2019-09-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No