Modulating the Skin Microbiome to Prevent Radiation Dermatitis in Breast Cancer
Acute radiation dermatitis (ARD) is the most common treatment-related adverse reaction following radiotherapy after modified radical mastectomy and/or prosthetic breast reconstruction in breast cancer patients. Moderate-to-severe ARD may compromise cosmetic outcomes and quality of life, and even impair radiotherapy eff
| Condition(s) | Skin Microbiome, Breast Cancer, Radiation Dermatitis |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | Acute radiation dermatitis (ARD) is the most common treatment-related adverse reaction following radiotherapy after modified radical mastectomy and/or prosthetic breast reconstruction in breast cancer patients. Moderate-to-severe ARD may compromise cosmetic outcomes and quality of life, and even impair radiotherapy efficacy. Current pharmacological prophylactic measures clinically employed - including topical corticosteroids, superoxide dismutase, and trolamine cream - demonstrate suboptimal efficacy and lack high-level evidence-based medical support. Emerging research indicates an association between cutaneous microbial homeostasis and ARD development, suggesting that maintaining skin surface acidity and modulating microecological balance may represent more effective preventive strategies |
| Who can participate | Inclusion Criteria: * Age ≥18 and \<70 years, with pathologically confirmed breast cancer; * TNM stage T1-3N1-3M0 or T3-4N0M0; * Underwent mastectomy with or without implant reconstruction; ④ Medically fit for adjuvant radiotherapy (i.e., in good general condition to tolerate expected side effects such as fatigue, nausea, or vomiting); ⑤ No concurrent use of other skincare products throughout the study period; * Voluntary participation with signed informed consent, agreeing to comply with investigator-directed use of the trial product. Exclusion Criteria: * Prior history of radiotherapy; * Severe systemic diseases (e.g., significant cardiac, hepatic, or renal dysfunction; immunocompromising conditions such as lymphoma, acquired immunodeficiency syndrome \[AIDS\], or Wiskott-Aldrich syndrom |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Lead sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Locations | Guangzhou, Guangdong, China |
| Start date | 2025-04-10 |
| NCT ID | NCT07066280 |
| Official listing | https://clinicaltrials.gov/study/NCT07066280 |