A Multi-Center, Randomized, Open-label, Parallel, Positive Controlled Trial for the Efficacy and Safety of Shouzu Ning Decoction in the Treatment of MKIs-induced grade II Hand-Foot Syndrome
- Conditions
- Hand-foot Syndrome
- Registration Number
- ITMCTR1900002760
- Lead Sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Male or female patients, age > 18 years;
2. Patients receiving MKIs for any malignancy;
3. Grade II hand-foot syndrome 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 (> 80 *10^9/L), Hb (> 90 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. Pre-existing dermopathy or drug allergy;
2. Concomitant administration of drugs that can cause HFS eg capecitabine, docetaxel, liposomal doxorubicin, etc. in four weeks;
3. Administration of drugs eg non-steroidal anti-inflammatory drugs and opioid analgesics, etc. confounding assessment of HFS;
4. Uncontrolled infections and metabolic diseases;
5. Coagulation disorders, known bleeding tendency or thrombophilia;
6. The investigators consider the patients are not suitable for this trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method recurrence rate;the change in hand-foot syndrome classification;
- Secondary Outcome Measures
Name Time Method safety;tthe quality of life score;