Examining the link between skin bacteria and radiation dermatitis in breast cancer patients
Official title: The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients Receiving Radiation After Mastectomy and Reconstructive Surgery
Run by Fudan University · NCT05032768 · Data updated 2026-11-12
This study looks at how the bacteria on the skin of breast cancer patients might affect the severity of skin problems caused by radiation treatment after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | January 1, 2021 |
| Main results expected | December 31, 2021 |
| Study ends | December 31, 2026 |
| Registry record updated | September 2, 2021 |
| Trial ID | NCT05032768 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are female patients with invasive breast cancer who have undergone mastectomy and breast reconstruction and are scheduled to receive radiotherapy.
✕Probably not a fit
Patients with previous breast or chest radiotherapy or serious skin diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on breast cancer patients who have undergone mastectomy and breast reconstruction followed by radiotherapy. It aims to systematically analyze the skin microbiome before and after radiotherapy to determine its association with the severity of radiation dermatitis. Given that a significant percentage of patients experience radiation dermatitis, understanding the role of the skin microbiome could provide insights into improving patient care. The study seeks to deepen the understanding of how skin microbiota interacts with skin physiology and immune responses during treatment.
Why it matters
Potential benefit: If successful, this study could lead to improved management and prevention strategies for radiation dermatitis in breast cancer patients.
How similar studies have gone: While previous studies have explored the effects of radiotherapy on skin and immune responses, this specific analysis of the skin microbiome in relation to radiation dermatitis is novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Xiaoli Yu, MD, Ph.D — Fudan University
- Study coordinator: Wei Shi, MD, Ph.D
- Email: wei.shi118@foxmail.com
- Phone: +86 18121299680
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.