Clinical trial · Observational
Study on Skin Microbiome of HFS
Study on Skin Microbiota of Hand Foot Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Microbiota | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine 150Mg Oral Tablet | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Control group
- description
- 20 healthy volunteers were included in the healthy control group
- label
- Disease group
- description
- 30 patients with advanced breast cancer developed hand-foot syndrome after capecitabine administration
- interventionNames
- Drug: Capecitabine 150Mg Oral Tablet
Primary outcomes (1)
- measure
- Transcriptional changes in skin microbiota
- timeFrame
- baseline,1 day, 21 days,42 days,65 days,85 days,106 days,127 days
- description
- The microbiota measured by 16S rRNA gene
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDWeese 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 23331690
- BACKGROUNDKong 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 22189793
- BACKGROUNDRoth 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 2645319