NCT04132713

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
Last Updated

October 21, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

October 17, 2019

Last Update Submit

October 18, 2019

Conditions

Microbiota

Keywords

skin microbiota16S rRNA genehand foot sysdombreast cancer chemotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Interventions

Capecitabine 150Mg Oral TabletDRUG

Advanced breast cancer patients with first-line medication

Disease group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients were included according to the inclusion and exclusion criteria

You may qualify if:

  • age: 18-65 years old
  • advanced breast cancer patients
  • healthy volunteers

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First affiliated hospital of Harbin medical university

Harbin, Heilongjiang, 150001, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 23331690BACKGROUND

  • 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.

    PMID: 22189793BACKGROUND

  • 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.

    PMID: 2645319BACKGROUND

MeSH Terms

Interventions

CapecitabineTablets

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesDosage FormsPharmaceutical Preparations

Central Study Contacts

Yunwei Wei, doctor

CONTACT

+86-0451-85553099hydwyw11@hotmail.com

xin Wu

CONTACT

+86-0451-85553099wuxin199509@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2019

First Posted

October 21, 2019

Study Start

September 10, 2019

Primary Completion

October 15, 2020

Study Completion

October 15, 2020

Last Updated

October 21, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)