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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| urea-based cream | Experimental | 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 |
|
| best supportive care | Placebo Comparator | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| urea-based cream | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheng-Long Ye, PHD | Zhongshan Hospital, Fudan University, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 301 Military Hospital, Beijing, China | Beijing | Beijing Municipality | 100039 | China | ||
| 302 Military Hospital, Beijing, China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15831268 | Result | Bosch FX, Ribes J, Cleries R, Diaz M. Epidemiology of hepatocellular carcinoma. Clin Liver Dis. 2005 May;9(2):191-211, v. doi: 10.1016/j.cld.2004.12.009. | |
| 11668491 | Result | 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. doi: 10.1002/ijc.1440. No abstract available. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
|
| The percentage of patients discontinuing treatment | starting sorafenib treatment within 12 weeks |
| Beijing |
| Beijing Municipality |
| 100039 |
| China |
| Union Hospital of Fujian Medical University, Fujian, China | Fuzhou | Fujian | 350001 | China |
| Guangdong Provincial People's Hospital, Guangdong, China | Guangzhou | Guangdong | 510080 | China |
| The Third Affiliated Hospital of Sun Yat-sen University, Guangdong, China | Guangzhou | Guangdong | 510630 | China |
| Heilongjiang Provincial Cancer Hospital, Heilongjiang, China | Haerbin | Heilongjiang | 150081 | China |
| The 81 Hospital of the Chinese People's Liberation Army, Nanjing, China | Nanjing | Jiangsu | 210002 | China |
| Jilin Provincial Tumor Hospital, Jilin, China | Changchun | Jilin | 130012 | China |
| Zhongshan Hospital, Fudan University, Shanghai | Shanghai | Shanghai Municipality | 200032 | China |
| Eastern Hepatobiliary Surgery Hospital of the Second Military Medical University, Shanghai, China | Shanghai | Shanghai Municipality | 200438 | China |
| Tianjin Cancer Hospital, Tianjin, China | Tianjin | Tianjin Municipality | 300060 | China |
| 14667750 | Result | Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1. |
| 9197213 | Result | 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. |
| 3719551 | Result | 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. doi: 10.1002/1097-0142(19860715)58:2+3.0.co;2-c. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |