Re-validating Prophylactic Efficacy of Urea-based Cream on Sorafenib-induced Hand-foot Skin Reaction in Patients With Advanced Hepatocellular Carcinoma

Methods

Patients

This study population consisted of patients with (1) HCC by proof of pathology, (2) presence of tumor thrombus in the main trunk of the portal vein or the first-order branches of the portal vein with minimal ascetics or with no ascetics by abdominal CT scan, (3) Child-Pugh liver function class A, (4) planning to receive oral sorafenib 400 mg twice per day, (5) age of 20 or more years old, and (6) able to communication in Chinese, Taiwanese or Hakka. Patients with (1) encephalopathy, psychosis, cognition impairment, blindness or hearing impairment, (2) allergic history to urea, (3) present ulceration, blisters, infective problems on the palms or soles, or (4) previous surgery, systematic chemotherapy or frequent radial ablation were excluded.

Research procedure

This is a randomized double-blind experiment study. Sample size was estimated by the G. power software version 3.1, which was set with logistic regression, odds ratio: 3.8, and power: 0.80. The estimated sample size should be 125 at least. This study, there was recruited 129 patients (43 patients in each groups). All eligible patients were recruited from Taipei Veterans General Hospital between January 1st and December 31th, 2014. They were randomly assigned in a ratio of 1:1:1 to treat with best supportive care plus moisturizing cream (A group), BSC plus 10% urea-based cream (B group) and BSC alone (group C which is comparison group),by method of EXCEL random sampling. A case manager recruited the eligible patients who also conducted informed consent and patient education. A research employee had responsibilities to record patients' demographic data, provide non-label cream and check previous container of the cream that should be exhausted. A medical oncologist or a nurse had responsibilities to assess patients' severity of HFSR and cutaneous wetness. The assessment was done on 3 days before starting sorafenib treatment and each 7 days after the starting, total 9 times. Creams were provided after the assessment. When patients developed HFSR, they will be referred to receive the most appropriate management.