OncoMatch/Clinical Trials/NCT07635277
Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury
Is NCT07635277 recruiting? Yes, currently enrolling (Jul 2026). This Phase 1 trial studies AKK Topical Preparation for radiation-induced skin injury.
Treatment: AKK Topical Preparation — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Head and Neck Squamous Cell Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: bacterial preparations
Previous treatment with other bacterial preparations
Cannot have received: bacterial therapy (clinical trial participation)
Participation in other bacterial therapy trials
Lab requirements
Blood counts
Adequate major organ function
Kidney function
Adequate major organ function
Liver function
Adequate major organ function
Cardiac function
Poorly controlled cardiac disease (NYHA class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmia requiring treatment) [excluded]
Adequate major organ function; Poorly controlled cardiac disease (NYHA class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmia requiring treatment) [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07635277 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior bacterial preparations, bacterial therapy (clinical trial participation) disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify