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

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000034406

Enrollment

Unknown

Registered

2020-07-04

Start date

2020-07-01

Completion date

Unknown

Last updated

2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand-foot Syndrome

Interventions

Case series:Shou-Zu-Ning Decoction

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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 50 ml/min) (Cockcroft-Gault formula); 6. Signed informed consent.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
the change in hand-foot syndrome classification;	—

Secondary

Measure	Time frame
the quality of life score;recurrence rate;safety;	—

Countries

China

Contacts

Public ContactQijin Shu

The First Affiliated Hospital of Zhejiang Chinese Medical University

shuqjhz@163.com+86 13605706566

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026