Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury

Korábbi kezelés

• 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
• Use of immunosuppressive drugs
• Any concomitant condition that, in the investigator's judgment, would compromise patient safety or study completion

Más betegség

• Cognitive impairment preventing understanding of the study
• 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)
• Poorly controlled cardiac disease (NYHA class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmia requiring treatment)
• 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
• Any other condition deemed unsuitable for enrollment by the investigator

Egyéb

• Use of antibiotics or antifungals within 1 month
• Symptomatic or rapidly progressive central nervous system metastases, extensive lung metastases causing dyspnea, tumor invading major vessels or nerves
• Pregnancy or breastfeeding
• Planned pregnancy from screening until 12 months after last treatment
• Inability to provide written informed consent

• 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