Modulating the Skin Microbiome to Prevent Radiation Dermatitis in Breast Cancer

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Jul 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new natural cream designed to help prevent skin problems called radiation dermatitis, which often happens to breast cancer patients after radiation treatment. Radiation dermatitis can cause skin redness, irritation, and discomfort, and may affect how well radiation works as well as the appearance of the skin. The trial is testing whether this special cream, which works by balancing the natural bacteria and acidity on the skin, can better protect the skin compared to regular moisturizers.

Women aged 18 to 70 who have early-stage breast cancer and are about to start radiation treatment after surgery may be eligible to join. Participants will use either the new cream or a standard moisturizer during their radiation therapy and will have their skin checked regularly to see how it responds. The study will also look at changes in the skin’s natural bacteria to understand how this affects skin health. This trial aims to find a safer and more effective way to reduce skin side effects from radiation, improving comfort and quality of life for breast cancer patients.

Gender

FEMALE

Eligibility criteria

• 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.