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Clinical study for external Chinese herbal medicine LC09 treating hand-foot skin reaction associated with theanti-tumor targeted drugs

Clinical study for external Chinese herbal medicine LC09 treating hand-foot skin reaction associated with theanti-tumor targeted drugs

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023679
Enrollment
Unknown
Registered
2019-06-07
Start date
2019-06-06
Completion date
Unknown
Last updated
2019-06-11

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

Conditions

Hand-foot skin reaction

Interventions

herbal group:herbal LC09 and routine care
control group:placebo and routine care

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Patients with malignant tumors diagnosed by pathology, including cancer of the liver and kidney cancer, lung cancer, etc. ? After the treatment of multi-kinase inhibitor targeted drugs, HFSR was more than 1 grade, including sorafenib sunitinib, etc. ? Aged 18 to 80 years. ? ECOG score 0 to 2. ? The expected survival period more than 3 months. ? No major organ dysfunction, the heart and liver renal function is basically normal, the test index reaches the following requirements: neutrophils >1.5x10^9/L, platelet >100x10^9/L, hemoglobin >90g/L; Bilirubin normal or < 1.5x ULN; AST ALT < 2.5 ULN. Serum creatinine <1.5 ULN; Endogenous creatinine clearance rate (Ccr) 60 ml/min(using Cockcroft-Gault formula). ? Understand the situation of this study, be able to cooperate with the evaluation of HFSR grading, and have signed informed consent.

Exclusion criteria

Exclusion criteria: ? Combined with the presence of other skin lesions in other extremities (such as diabetic or chemotherapeutic peripheral neuropathy). ? Other drugs that may affect HFSR have been planned (including the urea cream, a new pipion vitamin B6, etc.). ? There are serious uncontrolled organic lesions or infections, such as decompensated heart and lung renal failure, etc. which can not be tolerated by patients with anti-tumor treatment. ? Women during pregnancy or lactation. ? Participating in other clinical trials within or 4 weeks. ? Significant neuropsychiatric history, including dementia that may affect understanding and informed consent.

Design outcomes

Secondary

MeasureTime frame
Quality of Life;Targeted drug reduction incidence (%);Target drug withdrawal rate (%);Disease control rate (%);Time of tumor progression;

Primary

MeasureTime frame
The grade of HFSR;The pain score;

Countries

China

Contacts

Public ContactYanni Lou

China-Japan Friendship Hospital

louyanni@zryhyy.com.cn+86 010-84205733

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026