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

5 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Experimental: AKK Topical Preparation
Biologisch: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Grade ≥2 Acute Radiation Dermatitis
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in Skin Micro-Features on Digital Dermoscopy
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

West China Hospital

Medewerkers

West China-Jintang Hospital, Sichuan University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 juni 2026

Primaire voltooiing (Geschat)

30 november 2026

Studie voltooiing (Geschat)

31 december 2026

Studieregistratiedata

Eerst ingediend

3 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 juni 2026

Eerst geplaatst (Werkelijk)

9 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 september 2026

Laatste update ingediend die voldeed aan QC-criteria

5 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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