RecruitingPhase 1

Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury

China40 participantsStarted 2026-03-07

Plain-language summary

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 participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 tube…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Grade ≥2 Acute Radiation Dermatitis

Timeframe: From first radiotherapy fraction up to 90 days after the last fraction

Trial details

NCT IDNCT07635277

SponsorWest China Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

View on ClinicalTrials.gov More Radiation-Induced Skin Injury trials