Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury
ConditionRadiation-Induced Skin Injury
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Cognitive impairment preventing understanding of the study
Use of antibiotics or antifungals within 1 month
Previous treatment with other bacterial preparations
Participation in other bacterial therapy trials
Trial design
Treatments tested in this trial
- AKK Topical Preparation
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov