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New treatment option for Radiation-Induced Skin Injury
Official title Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury
ClinicalTrials.gov ID: NCT07635277
What this study is testing
What is AKK Topical Preparation?
AKK Topical Preparation is an investigational medicine, given as an once-weekly treatment applied to the skin, being studied as a potential treatment for radiation-induced skin injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.