Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury
Recruiting · NCT07635277 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
- Any abnormality (e.g., scar, tattoo) in the radiation field that would interfere with assessment
- Allergy to probiotics or any component of the study preparation; history of severe allergic reactions (e.g., anaphylaxis, angioedema, respiratory distress, allergic purpura, Arthus reaction)
- Use of immunosuppressive drugs
- Symptomatic or rapidly progressive central nervous system metastases, extensive lung metastases causing dyspnea, tumor invading major vessels or nerves
- Poorly controlled cardiac disease (NYHA class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmia requiring treatment)
- Pregnancy or breastfeeding
- Active tuberculosis, bacterial or fungal infection (grade ≥2 per CTCAE), or HIV infection
- Substance abuse or psychiatric disorder
- Active autoimmune disease or history thereof (exceptions: vitiligo, childhood asthma fully resolved with no intervention in adulthood)
- History of alcohol or drug abuse
- Planned pregnancy from screening until 12 months after last treatment
- Any concomitant condition that, in the investigator's judgment, would compromise patient safety or study completion
- Any other condition deemed unsuitable for enrollment by the investigator
- Inability to provide written informed consent
Where it is running
2 locations listed.
- West China Hospital of Sichuan University - Chengdu, Sichuan, China
- Jintang County First People's Hospital - Chengdu, Sichuan, China