Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Receiving immune checkpoint inhibitor therapy and clinically diagnosed with immune-related pruritus. 2) Having a pathologically confirmed diagnosis of a malignant solid tumor. 3) Aged between 18 and 80 years, regardless of gender. 4) Meeting the Traditional Chinese Medicine (TCM) syndrome diagnostic criteria for damp-heat pattern. 5) Willing to undergo the assigned treatment, observation, and all scheduled examinations, with good compliance, and must provide signed informed consent before enrollment. 6) Agreement not to participate in any other interventional clinical trials for immune-related adverse events during the study period.
Exclusion criteria
Exclusion criteria: 1) Presence of skin diseases caused by other etiologies. 2) History of allergy to Chinese herbal medicine. 3) Presence of uncontrolled severe hemorrhage or systemic infection, or having purulent and chronic infected wounds that are refractory to healing. 4) Comorbid with severe cardiovascular or cerebrovascular complications, active hepatitis, or severe hepatic or renal dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the Numerical Rating Scale (NRS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermatology Life Quality Index (DLQI) score;the immunotherapy discontinuation rate;changes in serum levels of inflammatory factors (IgE, IL-6, and TRPV1); | — |
Countries
China
Contacts
Beijing Hepingli hospital