Immune Checkpoint Inhibitor-related Rash, Immune-related Adverse Events
Conditions
Keywords
Wucao Anfu Formula, Traditional Chinese Medicine, Immune checkpoint inhibitor, Immune-related adverse event, Skin rash, External therapy
Brief summary
Immune checkpoint inhibitors have improved outcomes for patients with cancer, but immune checkpoint inhibitor-related skin rash is a common adverse event that may affect quality of life and continuation of anticancer therapy. This study aims to evaluate the efficacy and safety of Wucao Anfu Formula as an adjunctive treatment for immune checkpoint inhibitor-related rash. In this randomized controlled clinical study, eligible patients with grade 1-2 immune checkpoint inhibitor-related rash will be randomly assigned to receive standard topical corticosteroid treatment with or without Wucao Anfu Formula. The study will assess improvement of skin rash severity, symptoms, quality of life, and safety outcomes. The results may provide clinical evidence for integrative management of immune checkpoint inhibitor-related skin adverse events.
Detailed description
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.
Interventions
OTHERWucao Anfu Formula
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.
OTHERStandard management
Participants in the control group will receive standard management for immune checkpoint inhibitor-related rash according to clinical practice.
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blinded to the treatment allocation. Participants and care providers will not be blinded because the intervention involves external application of Wucao Anfu Formula. The investigators responsible for intervention administration will know the group allocation, but they will not participate in outcome assessment.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Both groups will receive standardized skin care and topical corticosteroid treatment. The intervention group will additionally receive Wucao Anfu Formula external wet compress therapy for 14 days.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rash Response Rate | 14 days after treatment initiation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Rash Severity Grade | 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. |
| Treatment-related Adverse Events | Baseline to 14 days after treatment initiation | Incidence and severity of adverse events during the study period. |
Outcome results
None listed