hand-foot skin reaction
Conditions
Interventions
Traditional Chinese Medicine Group:Shouzu Ning Decoction
Western Medicine Control Group:Urea Cream Combined with Compound Clobetasol Propionate
Sponsors
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1)Age =18 years, no restriction on sex; 2)Patients with advanced solid tumors receiving multi-kinase inhibitors (MKIs; such as anlotinib, apatinib, sorafenib, lenvatinib, sunitinib, regorafenib, fruquintinib, cabozantinib, or brivanib) as monotherapy, or in combination with immunotherapy (PD-1, PD-L1, or CTLA-4 inhibitors) or chemotherapy; 3)Diagnosis of grade 2 hand-foot skin reaction (HFSR) according to NCI-CTCAE v5.0 criteria; 4)ECOG performance status 0–1, and an expected survival of =3 months.
Exclusion criteria
Exclusion criteria: 1) Receipt of agents that may cause hand-foot syndrome (e.g., capecitabine, docetaxel, liposomal doxorubicin) within 4 weeks prior to study entry; 2) Receipt of agents that may cause peripheral sensory neuropathy (e.g., albumin-bound paclitaxel, paclitaxel, oxaliplatin) within 4 weeks prior to study entry; 3) Presence of systemic skin diseases or other hand-foot dermatologic conditions, such as psoriasis, eczema, diabetic foot, or distal peripheral neuropathy of the hands or feet; 4) Use of topical agents for HFSR (e.g., urea cream, corticosteroid ointments) within 1 week prior to study entry; 5) Use of oral analgesics for HFSR-related pain (e.g., NSAIDs such as celecoxib, ibuprofen; opioids such as oxycodone) or topical analgesics (e.g., NSAID gels like diclofenac, amide-type gels like lidocaine) within 1 week prior to study entry; 6) Dose reduction or interruption of MKI therapy; 7) Occurrence of other =grade 3 antitumor therapy–related adverse events besides HFSR; 8) Any other condition that, in the investigator's judgment, may interfere with the conduct of the study or affect the study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Rate of HFSR Treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Onset of HFSR Treatment;Change from Baseline in HF-QoL Scores;Change in TCM Syndrome Scores;Rate of MKI Treatment Discontinuation;Recurrence Rate of HFSR Treatment; | — |
Countries
China
Contacts
Public ContactQijin Shu
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed