Urea Cream Treatment Sorafenib-Associated HSFR in HCC

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2010

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: urea-based cream
    • 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
  • Placebo Comparator: best supportive care
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chinese Anti-Cancer Association
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sheng-Long Ye, PHD, Principal Investigator, Zhongshan Hospital, Fudan University, Shanghai, China

Citations Reporting on Results

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

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.

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

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.

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.

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