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

2026년 9월 5일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

40

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 중국
    • Sichuan
      • Chengdu, Sichuan, 중국, 610041
        • 모병
        • West China Hospital of Sichuan University
        • 연락하다:
      • Chengdu, Sichuan, 중국, 610400
        • 모병
        • Jintang County First People's Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Experimental: AKK Topical Preparation
생물학적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of Grade ≥2 Acute Radiation Dermatitis
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Changes in Skin Micro-Features on Digital Dermoscopy
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

West China Hospital

협력자

West China-Jintang Hospital, Sichuan University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 7일

기본 완료 (추정된)

2026년 11월 30일

연구 완료 (추정된)

2026년 12월 31일

연구 등록 날짜

최초 제출

2026년 6월 3일

QC 기준을 충족하는 최초 제출

2026년 6월 3일

처음 게시됨 (실제)

2026년 6월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 5일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 공유 지원 정보 유형

  • 연구_프로토콜

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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