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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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027518
Enrollment
Unknown
Registered
2019-11-17
Start date
2019-11-20
Completion date
Unknown
Last updated
2019-11-18

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

Conditions

Hand-foot Syndrome

Interventions

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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 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. 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.

Design outcomes

Primary

MeasureTime frame
the change in hand-foot syndrome classification;recurrence rate;

Secondary

MeasureTime frame
tthe quality of life score;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 10, 2026