Validation of the prophylactic efficacy of urea‐based creams on sorafenib‐induced hand‐foot skin reaction in patients with advanced hepatocellular carcinoma: A randomised experiment study

BACKGROUND: Hand‐foot skin reaction may influence the effectiveness of patients' treatment, patient quality of life, and the economics of health care. An effective prophylactic dermatological cream for preventing sorafenib‐induced hand‐foot skin reaction (HFSR) is yet to be identified. AIM: The aim of this study is validated the prophylactic efficacy of urea‐based creams on sorafenib‐induced hand‐foot skin reaction in patients with advanced hepatocellular carcinoma. METHODS: This was a randomised double‐blind experimental study. A total of 129 patients with advanced HCC were randomly assigned to three groups. The comparison group received best supportive care (BSC), group A received BSC plus a moisturising cream, and group B received BSC plus a 10% urea‐based cream. Incidence of HFSR and cutaneous wetness were assessed 3 days before starting sorafenib and each week after starting sorafenib for 8 weeks. RESULTS: No significant difference was observed in the incidence density of sorafenib‐induced HFSK (comparison group/A group, p > .05; comparison group/B group, p > .05). Group B reported significantly better cutaneous wetness of hands in the seventh week after starting sorafenib (p < .05) and of feet during the first 6 weeks (p < .05–.001). CONCLUSION: This study found a nut size amount of a 10% urea‐based cream applied twice a day can maintain patients' cutaneous wetness in the first 6 weeks after starting sorafenib than moisturising‐alone cream. But it cannot reduce the occurrence of HFSR. Thus, the result supports nut‐size dose of the 10% urea‐based cream three times a day may be an appropriate dose to prevent HFSR. Clinical Trail Registration Number: NCT04568330.