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Akkermansia Muciniphila (AKK) for Radiation-Induced Skin Injury (AKK-RIS)

5 septembre 2026 mis à jour par: Xuelei Ma MD, West China Hospital

Clinical Application of AKK Bacterial Preparation for the Treatment of Radiation-Induced Skin Injury

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

Background and Rationale Radiation-induced skin injury (RISI) affects approximately 95% of radiotherapy patients in China, with 85% experiencing moderate to severe acute radiation dermatitis (ARD). Current topical treatments have limited efficacy. Akkermansia muciniphila (AKK), a commensal gut bacterium, exhibits anti-inflammatory and barrier-repairing properties via NF-κB, Nrf2, and NLRP3 pathways. This is the first study to apply inactivated AKK topically for RISI.

Detailed Intervention The investigational product is an inactivated whole-cell AKK preparation (provided by State Key Laboratory of Biotherapy, Sichuan University). Participants apply 140 µL per 25 cm² of radiation field (delivering 7 × 10⁷ CFU) three times daily: once 1 hour before each radiotherapy fraction, and twice at other times (e.g., afternoon and bedtime). Treatment begins one day before the first fraction (after baseline skin sampling) and continues until 14 days after the last fraction.

Study Procedures After written informed consent, screening (D-28 to D-1) includes history, physical exam, and ECOG performance status. At baseline (D-1): skin microbiome sampling, digital dermoscopy, RTOG/CTCAE grading, and Skindex-16. During radiotherapy, weekly visits (on the first fraction day of each week, before that fraction) repeat all assessments. Treatment phase duration varies by fraction number (15, 25, 30, or 33 fractions). Follow-up visits occur at days 14 after the last fraction, with the same assessments. Adverse events are monitored throughout and graded by CTCAE v6.0.

Sample Size Justification Assuming historical incidence of grade ≥2 ARD = 50%, expected incidence with AKK = 30% (one-sided α=0.05, power=80%), the required sample size is 37. Accounting for 8% dropout, final N = 40.

Statistical Analysis Primary analysis uses intention-to-treat population. Incidence of grade ≥2 ARD will be compared to historical control using a one-sample proportion test. Secondary endpoints (skin microbiome, dermoscopy features, Skindex-16, adverse events) will be summarized descriptively with 95% confidence intervals. Continuous variables will be compared using paired t-tests or Wilcoxon signed-rank tests as appropriate.

Data Monitoring A Data Safety Monitoring Committee (DSMC) composed of oncologists, pharmacologists, biostatisticians, and GCP experts will review safety and efficacy data every 6 months and may recommend early termination or protocol modification based on predefined stopping rules (e.g., grade 4 AEs in >10% of participants).

Ethical Approval The protocol (version 2.0, 4 February 2026) and informed consent form (version 2.0, 4 February 2026) were approved by the Medical Ethics Committee of West China-Jintang Hospital, Sichuan University (approval No. 20260302002, dated 2 March 2026). Any amendments will be submitted for ethical review before implementation.

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chine
    • Sichuan
      • Chengdu, Sichuan, Chine, 610041
        • Recrutement
        • West China Hospital of Sichuan University
        • Contact:
      • Chengdu, Sichuan, Chine, 610400
        • Recrutement
        • Jintang County First People's Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Experimental: AKK Topical Preparation
Biologique: AKK Topical Preparation
Inactivated whole-cell Akkermansia muciniphila topical preparation. Dose: 140 µL per 25 cm² of radiation field (7 × 10⁷ CFU). Applied three times daily: once 1 hour before each radiotherapy fraction, and twice at other times (e.g., afternoon and bedtime). Treatment begins one day before the first radiotherapy fraction (after baseline skin sampling) and continues until 14 days after the last radiotherapy fraction.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of Grade ≥2 Acute Radiation Dermatitis
Délai: From first radiotherapy fraction up to 90 days after the last fraction
Proportion of participants developing grade 2 or higher acute radiation dermatitis (ARD) as assessed by RTOG and CTCAE v6.0 criteria during radiotherapy and follow-up.
From first radiotherapy fraction up to 90 days after the last fraction

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changes in Skin Micro-Features on Digital Dermoscopy
Délai: Baseline, weekly during radiotherapy, and at days 14, 30, 60, 90 after last radiotherapy fraction.
Evolution of skin micro-features (e.g., erythema, scaling, vascular changes) observed by digital dermoscopy during treatment and follow-up.
Baseline, weekly during radiotherapy, and at days 14, 30, 60, 90 after last radiotherapy fraction.
Skin Microbiota Composition
Délai: Same as above.
Changes in the relative abundance of skin bacterial species measured from desquamated scale samples.
Same as above.
Frequency of Grade ≥3 Acute Radiation Dermatitis
Délai: From first radiotherapy fraction to 90 days after last fraction.
Proportion of participants developing grade 3 or higher ARD assessed by RTOG/CTCAE v6.0.
From first radiotherapy fraction to 90 days after last fraction.
Duration of Grade 2/3/4 Acute Radiation Dermatitis
Délai: During radiotherapy and up to 90 days after last fraction.
Number of days from first onset to resolution of grade 2, 3, or 4 ARD.
During radiotherapy and up to 90 days after last fraction.
Incidence of Grade 2 ARD at 2 Weeks Post-Radiotherapy
Délai: Day 14 after last radiotherapy fraction.
Proportion of participants with grade 2 ARD at 14 days after the last radiotherapy fraction.
Day 14 after last radiotherapy fraction.
Frequency of Local Infection
Délai: From first radiotherapy fraction to 90 days after last fraction.
Occurrence of clinically diagnosed infection within the irradiated skin area.
From first radiotherapy fraction to 90 days after last fraction.
Other Adverse Events
Délai: From informed consent to 90 days after last radiotherapy fraction.
Type, frequency, severity, and relationship to study treatment of adverse events graded by CTCAE v6.0.
From informed consent to 90 days after last radiotherapy fraction.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

West China Hospital

Collaborateurs

West China-Jintang Hospital, Sichuan University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

7 juin 2026

Achèvement primaire (Estimé)

30 novembre 2026

Achèvement de l'étude (Estimé)

31 décembre 2026

Dates d'inscription aux études

Première soumission

3 juin 2026

Première soumission répondant aux critères de contrôle qualité

3 juin 2026

Première publication (Réel)

9 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 20260302002
  • AKK-RIS-2026-V2.0 (Autre identifiant: Jintang County First People's Hospital and West China Hospital)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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