Wucao Anfu Formula as Adjunctive Treatment for Immune Checkpoint Inhibitor-Related Rash
연구 개요
상태
상세 설명
mmune checkpoint inhibitors (ICIs) have become important treatments for various malignant tumors. However, immune-related adverse events, especially skin toxicities such as rash and dermatitis, occur frequently during ICI therapy and may negatively affect patients' quality of life and anticancer treatment adherence. Current management strategies mainly include skin care, antihistamines, and topical corticosteroids. Evidence regarding the role of traditional Chinese medicine-based external therapy as an adjunctive intervention remains limited.
This study is a multicenter, randomized, parallel-controlled clinical trial designed to evaluate the efficacy and safety of Wucao Anfu Formula as an adjunctive treatment for ICI-related rash. A total of 72 eligible participants with grade 1-2 ICI-related inflammatory skin rash will be randomly assigned in a 1:1 ratio to the intervention group or control group.
Both groups will receive standardized skin care and topical corticosteroid treatment. Participants in the intervention group will additionally receive Wucao Anfu Formula external wet compress therapy twice daily for 14 days. The control group will receive standard topical corticosteroid treatment alone.
The primary outcome is the overall improvement rate of ICI-related rash at day 14 after treatment. Secondary outcomes include changes in rash severity according to Common Terminology Criteria for Adverse Events (CTCAE), rash-related clinical symptoms and signs, itching severity, skin dryness, dermatology-specific quality of life, performance status, rescue treatment use, and safety outcomes including adverse events and laboratory examinations.
The study will provide clinical evidence regarding whether Wucao Anfu Formula can improve ICI-related rash while maintaining safety, and may contribute to the development of integrative approaches for managing immune-related adverse events during cancer immunotherapy.
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
1. Patients aged 18 years or older. 2. Patients with malignant tumors treated with immune checkpoint inhibitors who developed immune checkpoint inhibitor-related rash.
3. Patients meeting the diagnostic criteria for immune checkpoint inhibitor-related rash.
4. Patients voluntarily participating in the study and providing written informed consent.
Exclusion Criteria:
1. Patients with severe uncontrolled systemic diseases or serious organ dysfunction.
2. Patients with other skin diseases that may affect evaluation of rash. 3. Patients allergic to any component of Wucao Anfu Formula. 4. Pregnant or breastfeeding women. 5. Patients unable to complete the treatment protocol or follow-up. 6. Patients who withdraw informed consent voluntarily.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Wucao Anfu Formula Group
Participants in this group will receive Wucao Anfu Formula external therapy in addition to standard management for immune checkpoint inhibitor-related rash.
|
Wucao Anfu Formula is an external traditional Chinese medicine therapy.
Participants in the intervention group will receive Wucao Anfu Formula external wet compress therapy in addition to standard management for immune checkpoint inhibitor-related rash.
The intervention will be administered for 14 days according to the study protocol.
다른 이름들:
Participants in the control group will receive standard management for immune checkpoint inhibitor-related rash according to clinical practice.
|
|
활성 비교기: Control Group
Participants in this group will receive standard management for immune checkpoint inhibitor-related rash without Wucao Anfu Formula therapy.
|
Participants in the control group will receive standard management for immune checkpoint inhibitor-related rash according to clinical practice.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rash Response Rate
기간: 14 days after treatment initiation
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The proportion of participants achieving complete response or partial response of immune checkpoint inhibitor-related rash after treatment according to the Common Terminology Criteria for Adverse Events (CTCAE) criteria.
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14 days after treatment initiation
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Rash Severity Grade
기간: Baseline and 14 days after treatment initiation
|
Change in severity grade of immune checkpoint inhibitor-related rash assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) criteria before and after treatment.
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Baseline and 14 days after treatment initiation
|
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Treatment-related Adverse Events
기간: Baseline to 14 days after treatment initiation
|
Incidence and severity of adverse events during the study period.
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Baseline to 14 days after treatment initiation
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- TYLL2026[Z]字 072
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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