Urea Cream Treatment Sorafenib-Associated HSFR in HCC

Study Overview
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Brief Summary
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Although sorafenib is effective and safe in patients with advanced hepatocellular carcinoma (HCC), it increases dermatologic toxicities, including hand-foot skin reaction (HFSR), which may have a negative impact on patient quality of life (QoL). Urea-based creams may have a prophylactic effect on sorafenib-induced HFSR in HCC patients.

Detailed Description
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Mild hyperkeratosis is an early sign of HFSR and may sometimes be the only manifestation of sorafenib-associated HFSR. Urea is useful for the treatment of hyperkeratotic conditions and has been recommended for the treatment of multitargeted kinase inhibitor-related HFSR . To our knowledge, no randomized, controlled trials to date have evaluated treatments to prevent/palliate sorafenib-associated HFSR. We therefore tested the prophylactic effects of a urea-based cream on the incidence of HFSR associated with sorafenib treatment of patients with advanced HCC.

Official Title
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Randomized Controlled Phase II Study of the Prophylactic Effect of Urea-Based Cream on Sorafenib-Associated Hand-Foot Skin Reactions in Patients With Advanced Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: urea-based cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients with hepatocellular carcinoma will receive sorafenib per instructions of the package insert The patients with hepatocellular carcinoma must be willing to participate in this study and provide the investigators with written consents; The patients must be willing and able to complete the biweekly visits for the first 3 months; The patients must be willing and able to fill in the patient's efficacy questionnaires. If the patients cannot use pens or pencils, the patient's acquaintances or the clinical staffs will complete these questionnaires based on the answers provided by the patients The patients must discontinue all prior cancer treatment in at least 3 weeks before enrollment; The patient's life expectancy is ≥3 months The patients must provide written informed consents Exclusion Criteria: The patients participated in other clinical trials The patients received sorafenib therapy prior to enrollment The patients combined other treatment or used other biological therapy, chemotherapy, experimental treatment or radiotherapy The patient's sorafenib dosage exceeds 400mg, twice daily
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: urea-based cream<br>Advanced HCC throughout China were treated with 10% urea-based cream 3 times per day plus best supportive care, starting on day 1 of sorafenib treatment, for up to 12 weeks | Drug: urea-based cream<br>* urea-based cream (10% urea; Eucerin) 3 times per day plus best supportive care, starting on day 1 of sorafenib treatment, for a maximum of 12 weeks . BSC included the ad libitum use of non-urea-based moisturizing creams, alcohol-free moisturizer and petroleum jelly. Once HFSR occurred, patients were allowed any cream, including urea based creams, as guided by the investigator.<br>* Other names: Nexavar is the brand name of sorafenib;|
| Placebo Comparator: best supportive care<br>BSC included the ad libitum use of non-urea-based moisturizing creams, alcohol-free moisturizer and petroleum jelly. Once HFSR occurred, patients were allowed any cream, including urea based creams, as guided by the investigator | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of all-grade HFSR |  | Starting sorafenib treatment within 12 weeks | 
| Prophylactic topical application of ointment to reduce the hand-foot skin reactions in patients with hepatocellular carcinoma treated with sorafenib |  | Starting sorafenib treatment within 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of patients requiring sorafenib dose-reduction |  | Starting sorafenib treatment within 12 weeks | 
| The percentage of patients requiring discontinuation of sorafenib therapy |  | starting sorafenib treatment within 12 weeks | 
| The percentage of patients discontinuing treatment |  | starting sorafenib treatment within 12 weeks |