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Study on Skin Microbiome of HFS

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ClinicalTrials.gov Identifier: NCT04132713
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
Sponsor GmbH
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

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.

Condition or disease Intervention/treatment
Microbiota 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

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Study on Skin Microbiota of Hand Foot Syndrome
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patients were included according to the inclusion and exclusion criteria
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132713


Contacts
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Contact: Yunwei Wei, doctor +86-0451-85553099 hydwyw11@hotmail.com
Contact: xin Wu +86-0451-85553099 wuxin199509@163.com

Locations
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China, Heilongjiang
First affiliated hospital of Harbin medical university Recruiting
Harbin, Heilongjiang, China, 150001
Contact: Yunwei Wei    +86-0451-85553099    hydwyw11@hotmail.com   
Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University
Sponsor GmbH

Publications:
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Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT04132713     History of Changes
Other Study ID Numbers: Yunwei Wei 2019-09-12
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by First Affiliated Hospital of Harbin Medical University:
skin microbiota
16S rRNA gene
hand foot sysdom
breast cancer chemotherapy
Additional relevant MeSH terms:
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Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents