Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury
Sponsor: West China Hospital • ClinicalTrials.gov ID: NCT07635277
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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.
Interventions
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AKK Topical Preparation
(Biological)
Inactivated whole-cell Akkermansia muciniphila topical preparation. Dose: 140 µL per 25 cm² of radiation field (7 × 10⁷ CFU). Applied three times daily: once 1 hour before each radiotherapy fraction, and twice at other times (e.g., afternoon and bedtime). Treatment begins one day before the first radiotherapy fraction (after baseline skin sampling) and continues until 14 days after the last radiotherapy fraction.
Eligibility criteria
Conditions
Locations
- West China Hospital of Sichuan University — Chengdu, Sichuan, China
- Jintang County First People's Hospital — Chengdu, Sichuan, China
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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