Clinical trial Recruiting at 1 site Observational Ages 18 to 70 Women only

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.

More Breast Cancer trials

Quick facts

Study typeObservational
Ages18 Years to 70 Years
SexWomen only
Enrollment100 (estimated)
SponsorFudan University
Academic / other
Drugs / interventionsradiation
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedJanuary 1, 2021
Main results expectedDecember 31, 2021
Study endsDecember 31, 2026
Registry record updatedSeptember 2, 2021
Trial IDNCT05032768 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

  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.