The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients
Launched by FUDAN UNIVERSITY · Sep 1, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the relationship between skin changes caused by radiation therapy (called radiation dermatitis) and the types of bacteria that live on the skin (the skin microbiome) in women with breast cancer. The researchers want to determine if the skin microbiome can affect how severe these skin changes become after patients receive radiation treatment following breast surgery.
To participate in this trial, women must be between the ages of 65 and 74 and have been diagnosed with invasive breast cancer. They should have had a mastectomy and breast reconstruction, followed by radiation therapy. Participants will need to sign a consent form and have a good overall health score. Those with previous radiation treatment to the breast, serious skin conditions, or who are pregnant cannot join the study. If eligible, participants can expect to have their skin microbiome analyzed before and after radiation therapy to help understand its role in skin reactions. This research aims to improve care for future patients undergoing similar treatments.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • 1. Female patients
- • 2. Invasive breast cancer confirmed by pathology
- • 3. Underwent mastectomy and breast reconstruction
- • 4. Radiotherapy after breast reconstruction
- • 5. ECOG score 0-1
- • 6. Signed informed consent
- Exclusion Criteria:
- • 1. Previous breast or chest radiotherapy
- • 2. Other serious skin diseases (systemic lupus erythematosus, skin sclerosis, et al) and cannot receive radiotherapy
- • 3. Pregnant women
- • 4. Patients who are unwilling or unable to receive regular follow-up.
About Fudan University
Fudan University, a prestigious comprehensive research university located in Shanghai, China, is committed to advancing medical science through innovative clinical research. Renowned for its rigorous academic standards and cutting-edge research facilities, Fudan University plays a pivotal role in the global health landscape by sponsoring a diverse array of clinical trials aimed at improving patient outcomes and addressing pressing medical challenges. Leveraging its multidisciplinary expertise and collaborative networks, the university strives to translate scientific discoveries into practical applications, fostering advancements in healthcare and contributing to the well-being of communities both locally and internationally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
Patients applied
Trial Officials
Xiaoli Yu, MD, Ph.D
Principal Investigator
Fudan University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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