Could a probiotic cream shield cancer patients from radiation burns?
NCT ID NCT07635277
First seen Jun 24, 2026 · Last updated Sep 10, 2026 · Updated 5 times
Summary
This early-stage trial tests a cream made from inactivated Akkermansia muciniphila bacteria to prevent skin injury in 40 breast or head/neck cancer patients receiving radiation. The cream is applied three times daily to the radiation area. The main goal is to see if it is safe and tolerable, and to measure how many patients develop moderate to severe skin reactions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- inactivated Akkermansia muciniphila bacteria (topical preparation)
- What this could lead to
- If it works, this could point toward a simple cream to prevent or reduce skin damage from radiation therapy.
- What could go wrong
- This is a very early Phase 1 trial with only 40 people, so it is mainly checking safety. It may not prove effective, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Jintang County First People's Hospital
RECRUITINGChengdu, Sichuan, 610400, China
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West China Hospital of Sichuan University
RECRUITINGChengdu, Sichuan, 610041, China
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