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Study on Skin Microbiome of HFS

Study on Skin Microbiota of Hand Foot Syndrome

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04132713
Enrollment
50
Registered
2019-10-21
Start date
2019-09-10
Completion date
2020-10-15
Last updated
2019-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbiota

Keywords

skin microbiota, 16S rRNA gene, hand foot sysdom, breast cancer chemotherapy

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

Interventions

DRUGCapecitabine 150Mg Oral Tablet

Advanced breast cancer patients with first-line medication

Sponsors

Sponsor GmbH
CollaboratorOTHER
First Affiliated Hospital of Harbin Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Transcriptional changes in skin microbiotabaseline,1 day, 21 days,42 days,65 days,85 days,106 days,127 daysThe microbiota measured by 16S rRNA gene

Countries

China

Contacts

Primary ContactYunwei Wei, doctor
hydwyw11@hotmail.com+86-0451-85553099
Backup Contactxin Wu
wuxin199509@163.com+86-0451-85553099

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026