Clinical trial · Observational
The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients
The Association Between Radiation Dermatitis and Skin Microbiome in Breast Cancer Patients Receiving Radiation After Mastectomy and Reconstructive Surgery
NCT05032768CI-TRIAL-00053656recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The breast cancer patients who received radiotherapy after mastectomy and breast reconstruction will be enrolled. The skin microbiome before radiotherapy and its changes after radiotherapy will be analyzed systematically to find out whether the skin microbiome is associated with the severity of radiation dermatitis.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Dermatitis | — | UNRESOLVED | — |
| Reconstructive Surgery | — | UNRESOLVED | — |
| Skin Microbiome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| post-operative radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Severe radiation dermatitis
- description
- RTOG/EORTC grade 2 and above
- interventionNames
- Radiation: post-operative radiotherapy
- label
- No or mild radiation dermatitis
- description
- RTOG/EORTC grade 0 or 1
- interventionNames
- Radiation: post-operative radiotherapy
Primary outcomes (1)
- measure
- Skin microbiome differences between patients with and without >=2 acute radiation dermatitis
- timeFrame
- 3 months
- description
- Acute radiation dermatitis will be graded per the Toxicity Criteria of the Radiation Therapy Oncology Group (RTOG)
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.