Study on the Prevention of Dermal Toxicity Caused by Regorafenib by Traditional Chinese Medicine TDX105
Hand and Foot Skin Reaction, Colorectal Cancer Stage IV
About this trial
This is an interventional prevention trial for Hand and Foot Skin Reaction
Eligibility Criteria
Inclusion Criteria:
- Clinically confirmed colorectal cancer patients;
- It is planned to use the targeted drug regorafenib for the first time, and the initial dose is 120mg/d;
- Performance Status score ≤3;
- Age ≥18; 5, no intellectual and mental disorders, normal language expression ability, ability to judge their own symptoms
6. Understand and agree to accept the treatment, and sign the informed consent.
Exclusion Criteria:
- Patients with skin reactions affected by simultaneous use of other targeted drugs (sorafenib, sunitinib, fruquintinib, etc.), chemotherapy drugs (capecitabine, doxorubicin, etc.) or hand-foot radiotherapy;
- Patients with skin diseases such as eczema, psoriasis and tinea pedis at observed skin sites (namely hands and feet); Patients with skin allergic diseases;
- Patients in the study who cannot cooperate with the continuation of this treatment;
- Sudden changes in the patient's condition affected and interfered with the researcher
Sites / Locations
- Cancer hospital Chinese academy of Medical sciences
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Traditional chinese medicine TDX105
placebo
Experimental group Traditional chinese medicine TDX105 (Dissolve in warm water and then dilute to 600ml and soak hands and feet for 30 minutes each time, once in the morning and evening every day, until the end of the first 8 weeks of treatment with regorafenib) Basic care was the same in both groups, including routine care such as topical use of urea ointment
The control group received placebo granules mixed with dextrin and food coloring (Dissolve in warm water and then dilute to 600ml and soak hands and feet for 30 minutes each time, once in the morning and evening every day, until the end of the first 8 weeks of treatment with regorafenib) - Basic care was the same in both groups, including routine care such as topical use of urea ointment