NCT07066280

Modulating the Skin Microbiome to Prevent Radiation Dermatitis in Breast Cancer

Skin Repairing Cream for the Prevention of Radiation Dermatitis and Regulation of Skin Microbial Environment in Breast Cancer: A Multicenter, Prospective, Randomized Controlled Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 326 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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. This study evaluates the efficacy and safety of a natural weak-acid macromolecular/small molecular repair cream in preventing ARD among post-operative breast cancer patients receiving radiotherapy through skin microbiome modulation. We enrolled 326 high-risk early-stage breast cancer patients scheduled for post-operative radiotherapy and randomized them to compare the superiority of the natural weak-acid repair cream versus conventional care with moisturizer. Concurrent skin microbiome sampling was performed to assess microecological changes and their impact on ARD development. The findings will provide high-level clinical evidence and theoretical basis for the safer and more effective application of this natural weak-acid repair cream in preventing post-radiotherapy ARD in breast cancer patients.

Conditions

• Skin Microbiome
• Breast Cancer
• Radiation Dermatitis

Interventions

Type	Name	Description
DRUG	Skin Repairing Cream	Skin Repairing Cream containing natural weak-acid
OTHER	Cetaphil® Moisturizing Cream as Inactive Control	Cetaphil® Moisturizing Cream

Timeline

• Start date: 2025-04-10
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2025-07-15
• Last updated: 2025-07-15

Locations

1 site across 1 country: China