Efficacy and Safety of Shou-Zu-Ning Decoction in the Treatment of MKIs-induced grade III Hand-Foot Syndrome: a Prospective, Open, One-arm, Multi-Center Trial

Phase 1

• Conditions: Hand-foot Syndrome

• Registration Number: ITMCTR2000003455
• Lead Sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female patients aged > 18 years;
2. Patients receiving MKIs for any malignancy;
3. Grade III 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.

Exclusion Criteria

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. Uncontrolled infections and metabolic diseases;
4. Coagulation disorders, known bleeding tendency or thrombophilia;
5. 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
the change in hand-foot syndrome classification;

Secondary Outcome Measures

Name	Time	Method
safety;recurrence rate;the quality of life score;