Efficacy and safety of traditional Chinese medicine herbal hand-foot bath combined with arnebia oil for chemotherapy-induced hand-foot syndrome refractory to standard treatment: a single-arm prospective interventional pilot study of 30 cases.

BACKGROUND: Chemotherapy-induced hand-foot syndrome (HFS) is a common dose-limiting cutaneous adverse reaction associated with cytotoxic agents such as capecitabine and small-molecule targeted drugs. Severe HFS may lead to dose reduction or interruption of antitumor treatment, significantly impairing patients' quality of life and treatment compliance. Current standard treatments (urea ointment, vitamin B6, topical corticosteroids, etc.) show limited efficacy for some patients with moderate-to-severe HFS, creating an urgent clinical need for additional supportive interventions. METHODS: This was a single-arm prospective interventional pilot study. It enrolled 30 consecutive patients with solid tumors who received capecitabine-based antitumor therapy or oral targeted therapy, developed HFS ≥ grade 1, and were refractory to standard treatment between November 1, 2025 and April 2026 at the Department of Medical Oncology, The Second Affiliated Hospital of Zhejiang University School of Medicine. All patients received a prespecified combined regimen consisting of self-formulated Yiqi Huoxue Tongluo herbal bath and external arnebia oil. Source-record review showed that the external treatment was initiated during the antitumor drug administration period; for patients receiving capecitabine, treatment generally began on cycle day 2-3 rather than during a scheduled rest period. The primary endpoint was the observed response rate, defined as a reduction in HFS grade by ≥1 grade. Secondary endpoints included complete remission rate, time to improvement, proportion of patients maintaining the original capecitabine dose, two-cycle follow-up recurrence/worsening, and safety. Missing efficacy data were described without imputation. RESULTS: Thirty patients were enrolled, with a mean age of 59.0±12.4 years and 60.0% male. Baseline HFS grade was grade 1 in 2 patients (6.7%), grade 2 in 24 (80.0%), and grade 3 in 4 (13.3%). Twenty-eight patients had complete efficacy evaluation. The observed overall response rate was 85.7% (24/28), complete remission rate was 7.1% (2/28), and the mean reduction in HFS grade was 0.9. The median time to improvement was 7 days (range 3-28 days). In total, 82.1% (23/28) of evaluable patients maintained the original antitumor regimen without capecitabine dose reduction. During two subsequent treatment cycles of follow-up, no recurrence or worsening of HFS was documented; four patients discontinued capecitabine because of disease change, and 25 patients continued the original capecitabine dose. No severe adverse events related to the combined external regimen were observed. CONCLUSIONS: Yiqi Huoxue Tongluo herbal bath combined with external arnebia oil showed preliminary signals of effectiveness and favorable safety in chemotherapy-induced HFS refractory to standard treatment. Because this single-arm pilot study lacked a concurrent control group, causal inference is limited and the findings should be interpreted as hypothesis-generating pending confirmation in controlled prospective trials.