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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
871
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.
301 Military Hospital, Beijing, China
Beijing, Beijing Municipality, China
302 Military Hospital, Beijing, China
Beijing, Beijing Municipality, China
Union Hospital of Fujian Medical University, Fujian, China
Fuzhou, Fujian, China
The incidence of all-grade HFSR
Time frame: 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
Time frame: Starting sorafenib treatment within 12 weeks
The percentage of patients requiring sorafenib dose-reduction
Time frame: Starting sorafenib treatment within 12 weeks
The percentage of patients requiring discontinuation of sorafenib therapy
Time frame: starting sorafenib treatment within 12 weeks
The percentage of patients discontinuing treatment
Time frame: starting sorafenib treatment within 12 weeks
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Guangdong Provincial People's Hospital, Guangdong, China
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University, Guangdong, China
Guangzhou, Guangdong, China
Heilongjiang Provincial Cancer Hospital, Heilongjiang, China
Haerbin, Heilongjiang, China
The 81 Hospital of the Chinese People's Liberation Army, Nanjing, China
Nanjing, Jiangsu, China
Jilin Provincial Tumor Hospital, Jilin, China
Changchun, Jilin, China
Zhongshan Hospital, Fudan University, Shanghai
Shanghai, Shanghai Municipality, China
Eastern Hepatobiliary Surgery Hospital of the Second Military Medical University, Shanghai, China
Shanghai, Shanghai Municipality, China
...and 1 more locations