Urea Cream Treatment Sorafenib-Associated HSFR in HCC

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01934829
• Other study ID #: 1163
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2013
• Last updated: August 30, 2013
• Start date: July 2009
• Est. completion date: July 2010

Study information

• Verified date: August 2013
• Source: Chinese Anti-Cancer Association
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 871
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• urea-based cream
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.

Locations

Country	Name	City	State
China	301 Military Hospital, Beijing, China	Beijing	Beijing
China	302 Military Hospital, Beijing, China	Beijing	Beijing
China	Jilin Provincial Tumor Hospital, Jilin, China	Changchun	Jilin
China	Union Hospital of Fujian Medical University, Fujian, China	Fuzhou	Fujian
China	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	Eastern Hepatobiliary Surgery Hospital of the Second Military Medical University, Shanghai, China	Shanghai	Shanghai
China	Zhongshan Hospital, Fudan University, Shanghai	Shanghai	Shanghai
China	Tianjin Cancer Hospital, Tianjin, China	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Anti-Cancer Association

Country where clinical trial is conducted

China, 

References & Publications (5)

Bosch FX, Ribes J, Cléries R, Díaz M. Epidemiology of hepatocellular carcinoma. Clin Liver Dis. 2005 May;9(2):191-211, v. Review. — View 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): — View Citation

Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. Review. — View Citation

Parkin DM, Bray F, Ferlay J, Pisani P. Estimating the world cancer burden: Globocan 2000. Int J Cancer. 2001 Oct 15;94(2):153-6. — View Citation

Young JL Jr, Ries LG, Silverberg E, Horm JW, Miller RW. Cancer incidence, survival, and mortality for children younger than age 15 years. Cancer. 1986 Jul 15;58(2 Suppl):598-602. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of all-grade HFSR		Starting sorafenib treatment within 12 weeks	No
Primary	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	No
Secondary	The percentage of patients requiring sorafenib dose-reduction		Starting sorafenib treatment within 12 weeks	Yes
Secondary	The percentage of patients requiring discontinuation of sorafenib therapy		starting sorafenib treatment within 12 weeks	Yes
Secondary	The percentage of patients discontinuing treatment		starting sorafenib treatment within 12 weeks	Yes