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Could a probiotic cream shield cancer patients from radiation burns?

NCT ID NCT07635277

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Jintang County First People's Hospital

    RECRUITING

    Chengdu, Sichuan, 610400, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

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