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Modulating the Skin Microbiome to Prevent Radiation Dermatitis in Breast Cancer

RecruitingPhase 3Ages 18 Years - 70 YearsFemaleSun Yat-Sen Memorial Hospital of Sun Yat-Sen Univ…
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In plain words

What the trial is, and whether it could suit you

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 molecula

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📋 Eligibility rules (as published)
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 syndrome) or history of other malignancies; ③ Skin reactions due to systemic therapies (e.g., chemotherapy, immunotherapy) or active dermatologic conditions in the treatment area; * Known hypersensitivity to the natural weak-acid macromolecular/small molecular repair cream or any of its components; ⑤ Current participation in other clinical trials or participation within the past 3 months, or judged by investigators to have poor compliance that would prevent completion of the study.
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What it tests

  • Skin Repairing Cream
  • Cetaphil® Moisturizing Cream as Inactive Control
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Where

1 site
Sun Yat-sen Memorial Hospital
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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