Clinical trial NCT01934829: Urea Cream Treatment Sorafenib-Associated HSFR in HCC
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Chinese Anti-Cancer Association
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 871
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of all-grade HFSR
timeFrame: Starting sorafenib treatment within 12 weeks
measure: Prophylactic topical application of ointment to reduce the hand-foot skin reactions in patients with hepatocellular carcinoma treated with sorafenib
timeFrame: Starting sorafenib treatment within 12 weeks
Secondary outcomes:
measure: The percentage of patients requiring sorafenib dose-reduction
timeFrame: Starting sorafenib treatment within 12 weeks
measure: The percentage of patients requiring discontinuation of sorafenib therapy
timeFrame: starting sorafenib treatment within 12 weeks
measure: The percentage of patients discontinuing treatment
timeFrame: starting sorafenib treatment within 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: 301 Military Hospital, Beijing, China
state: Beijing
city: Beijing
country: China
facility: 302 Military Hospital, Beijing, China
state: Beijing
city: Fuzhou
country: China
facility: Union Hospital of Fujian Medical University, Fujian, China
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital, Guangdong, China
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University, Guangdong, China
state: Guangdong
city: Haerbin
country: China
facility: Heilongjiang Provincial Cancer Hospital, Heilongjiang, China
state: Heilongjiang
city: Nanjing
country: China
facility: The 81 Hospital of the Chinese People's Liberation Army, Nanjing, China
state: Jiangsu
city: Changchun
country: China
facility: Jilin Provincial Tumor Hospital, Jilin, China
state: Jilin
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University, Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital of the Second Military Medical University, Shanghai, China
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Cancer Hospital, Tianjin, China
state: Tianjin
Study officials:
affiliation: Zhongshan Hospital, Fudan University, Shanghai, China
name: Sheng-Long Ye, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1.
citation: Chang MH, Chen CJ, Lai MS, Hsu HM, Wu TC, Kong MS, Liang DC, Shau WY, Chen DS. Universal hepatitis B vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. Taiwan Childhood Hepatoma Study Group. N Engl J Med. 1997 Jun 26;336(26):1855-9. doi: 10.1056/NEJM199706263362602.
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