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

2026年9月5日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

40

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • 中国
    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • 募集
        • West China Hospital of Sichuan University
        • コンタクト：
      • Chengdu、Sichuan、中国、610400
        • 募集
        • Jintang County First People's Hospital
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Experimental: AKK Topical Preparation
生物学的：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Incidence of Grade ≥2 Acute Radiation Dermatitis
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Changes in Skin Micro-Features on Digital Dermoscopy
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

West China Hospital

協力者

West China-Jintang Hospital, Sichuan University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月7日

一次修了 (推定)

2026年11月30日

研究の完了 (推定)

2026年12月31日

試験登録日

最初に提出

2026年6月3日

QC基準を満たした最初の提出物

2026年6月3日

最初の投稿 (実際)

2026年6月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月9日

QC基準を満たした最後の更新が送信されました

2026年9月5日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 20260302002
  • AKK-RIS-2026-V2.0 (その他の識別子：Jintang County First People's Hospital and West China Hospital)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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