A Prospective, Open, Single-Arm, Multi-Center Clinical Study on the Efficacy and Safety of Pi-Yan-Ning Decoction in the Treatment of Grade III Skin Rash Induced by Anti-Tumor Targeted Drugs
- Conditions
- Skin Rash Induced by Anti-tumor Targeted Drugs
- Registration Number
- ITMCTR2000003532
- Lead Sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Male or female patients aged >18 years;
2. Patients receiving anti-tumor targeted drugs;
3. Grade III rash according to NCI-CTC 5.0 standard;
4. KPS > 60, life expectancy >=3 months;
5. The functional level of major organs met the following criteria:
1) ANC (>= 1.5 *10^9/L), PLT (>= 75 *10^9/L), Hb (>= 80 g/L);
2) TBIL < 1.5 ULN, ALT, AST < 2.5 ULN, with liver metastasis < 5 ULN, BUN and Cr <= 1 ULN or endogenous creatinine clearance (>=50 ml/min) (Cockcroft-Gault formula);
6. Signed informed consent.
1. Skin lesions or skin diseases considered to affect the study, or history of allergic contact with other drugs;
2. Received hormones or antibiotics or any other drugs that may affect the skin rash within 1 week before the start of our research, including Chinese patent medicine and herbal medicine;
3. Serious or uncontrollable systemic diseases (such as unstable respiration, circulation, digestion, urinary and blood system diseases, ect.);
4. Previous history of neurological or mental disorders, including epilepsy and dementia;
5. Pregnancy or lactation;
6. The subject was considered not be able to complete the study or comply with the requirements of this study (due to management or other reasons).
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cure rate;Effective time;Partial response rate;Total effective rate;Changes of rash classification;
- Secondary Outcome Measures
Name Time Method Recurrence rate;Safety evaluation;Quality of life assessment;Completion rate of original anti-tumor treatment intensity;