Examining the link between skin bacteria and radiation dermatitis in breast cancer patients
The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients Receiving Radiation After Mastectomy and Reconstructive Surgery
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05032768 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are female patients with invasive breast cancer who have undergone mastectomy and breast reconstruction and are scheduled to receive radiotherapy.
Not a fit: Patients with previous breast or chest radiotherapy or serious skin diseases may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.