Hand-Foot-Skin reaction
Conditions
Interventions
Western medicine group:SND placebo+Urea Cream+Clobetasol Propionate Ointment
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Provide informed consent prior to any study-specific procedures 2. Patients aged > 18 years; 3. Patients with advanced solid tumours receiving single VEGFR-TKIs (anilotinib, apatinib, sorafenib, lenvatinib, sunitinib, regorafenib, cabozantinib, brinilib, etc.) or combined with immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4 inhibitors) ; 4. Grade II Hand-Foot-Skin reaction according to NCI-CTC 5.0 standard; 5. Traditional Chinese medicine (TCM) syndrome in patients with Grade II hand-foot skin reaction (HFSR) is the heat toxicity and blood stasis syndrome; 6. Good physical condition, ECOG 0-1, life expectancy =3 months;
Exclusion criteria
Exclusion criteria: 1. Concomitant administration of drugs that can cause HFS eg capecitabine, docetaxel, liposomal doxorubicin, etc. in four weeks; 2. Concomitant administration of drugs that can cause capecitabine eg paclitaxel (Albumin Bound), paclitaxel, oxaliplatin, etc. in four weeks; 3. Any systemic dermatoses or other dermatologic lesions of the hands and feet eg psoriasis, eczema, diabetic foot, peripheral nerve injury of hands and feet, etc; 4. Concomitant administration of drugs that treat HFSR eg urea ointment, hormone ointment, etc.in one week; 5. Concomitant administration of drugs that treat HFSR-related pain eg nonsteroidal antiinflammatory drugs (celecoxib, ibuprofen, etc.), opioids (OxyContin, Meconidine, etc.) by oral formulation, as well as a nonsteroidal anti-inflammatory drug (Furtaradin, etc.), and amides (Lidocaine gel, etc.), etc. for external use, in one week; 6. Reduction or interruption of VEGFR-TKIs; 7. Evidence of other grade 3 or higher antitumor therapy-related adverse reactions other than HFSR; 8. The investigators consider the patients are not suitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of HFSR (Proportion of patients with HFSR reduced to grade 0-1 after 6 weeks); | — |
Secondary
| Measure | Time frame |
|---|---|
| HF-QoL scores;the safety of SND;Changes in biomarkers (ANXA1 ANXA2 ANXA5 Cath-D FABP5 GSTP1 HMGB1 IGFBP7 PA2G4);Type, incidence, severity and causality of adverse reactions; | — |
Countries
China
Contacts
Public ContactQijin Shu
The First Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed