Clinical Research Directory

Traditional Chinese Medicine Treatment for Capecitabine-Related Hand-Foot Syndrome

This study is a prospective, single-center, randomized, parallel-group, open-label clinical trial titled "Intervention with the 'Xu Xue Tong Luo Traditional Chinese Medicine Compound for Capecitabine-Related Hand-Foot Syndrome." The research hypothesis is that adding this traditional Chinese medicine hand and foot bath to standard baseline care will result in a significantly higher efficacy rate-defined as a ≥1-grade reduction in Hand-Foot Syndrome (HFS) severity after 3 weeks-compared to baseline care alone.The study plans to enroll 110 patients with capecitabine-related Grade 1-2 HFS (with some eligible Grade 3 patients), who will be randomized in a 1:1 ratio to the control group and the intervention group. The control group will receive standard baseline care; the intervention group will receive standard baseline care supplemented with a fixed 12-ingredient traditional Chinese medicine hand-and-foot bath, in which processed Aconite is pre-decocted to reduce toxicity. Patients will soak their hands and feet in the decoction at 38-41°C at least 4 times per week for 3 consecutive weeks.Primary endpoint: The proportion of patients with a ≥1-grade reduction in HFS score from baseline after 3 weeks of intervention.