Clinical Application of AKK Bacterial Preparation for the Treatment of Radiation-Induced Skin Injury
This study is a multicenter, open-label, Phase I single-arm clinical trial evaluating the safety and tolerability of a topical AKK probiotic preparation (Akkermansia muciniphila) for the prevention and treatment of radiation-induced skin injury in patients receiving radiotherapy for breast cancer, head and neck cancer (including nasopharyngeal carcinoma). A total of 40 participants are planned to receive the AKK preparation applied to the radiation field three times daily, starting one day before the first radiotherapy fraction and continuing until 14 days after the last fraction. The primary outcome is the incidence of grade ≥2 acute radiation dermatitis (ARD) assessed by RTOG and CTCAE criteria. Secondary outcomes include changes in skin micro-features under digital dermoscopy, skin microbiota composition, quality of life (Skindex-16), and safety.
• Diagnosis of breast cancer, head and neck cancer (including nasopharyngeal carcinoma) receiving radiotherapy
• Age ≥18 years and ≤75 years, any sex
• Signed written informed consent
• Radiation field skin area can be localized and skin inflammation can be assessed
• ECOG performance status 0-1, life expectancy ≥3 months
• Adequate major organ function
• Fertile patients (both sexes) must use effective medical contraception during the study and for 6 months after the last dose
• Willing to comply with follow-up and skin image collection