Malignancy targets drug-related skin reactions of the hands and feet
Conditions
Interventions
Experimental group:TDX105 granules + basic treatment
Control group:10% urea cream + basic therapy
Sponsors
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Clearly diagnosed as malignant tumor, and receive targeted drug treatment within the standard dose range, including MKIs, VEGFR-TKIs, EGFR-TKIs, EGFR monoclonal antibodies, etc., representative drugs include but are not limited to sorafenib, regfinib, cabozotinib, apatinib, gefitinib, erlotinib, cetuximab, axitinib, pazopanib, sildenib (AZD2171). 2. Hand and foot skin reactions after targeted drug treatment were diagnosed as Hand and Foot Skin Reactions (HFSR) grade I-II according to the NCI-CTCAE 5.0 skin adverse reaction grading standard. 3. Age 18~75 years old (including boundary value). 4. ECOG PS score = 3 months. 5. Agree to participate in this study and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Squamous cell carcinoma in situ, melanoma, Paget disease and other skin malignancies. 2. Skin metastasis of solid tumors and skin manifestations of hematologic malignancies. 3. There are skin toxic reactions caused by non-malignant tumor targeted therapy drugs, such as chemotherapy-related HFSR, radiation dermatitis, and skin damage manifestations of immunotherapy-related adverse events (irAEs), such as Stevens-Johnson syndrome. 4. Those who need to use antibiotics, anti-allergic drugs, or hormones for any reason. 5. Combined with skin damage or lesions caused by other causes, including the observed skin lesion site combination: acne, eczema, psoriasis and other primary skin lesions; Peripheral neuropathy caused by diabetes; Fungal infections of the skin; Skin trauma and inflammation. 6. Users who reduce the amount of targeted drugs due to side reactions of targeted drugs or other reasons. 7. Those who are pregnant, lactating or planning to become pregnant within 6 months after the end of the study. 8. Have infectious diseases or serious underlying diseases, including but not limited to immune system, blood system, circulatory system, digestive system, respiratory system, urinary system, nervous system and mental system, and are assessed by the investigator as not suitable to participate in this study. 9. Known allergy to the drug in this study. 10. Is participating in clinical trials of other drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade of skin toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hand-foot skin reactions and quality of life questionnaire,HF-QOL;Dermatological Quality of Life Questionnaire score,DLQI;Numerical Rating Scale, NRS;Visual analogue score,VAS;Effective/healing time;Time to recurrence after effective/healing;Lesion appearance; | — |
Countries
China
Contacts
Public ContactGuowang Yang
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Outcome results
None listed