Urea Cream Treatment Sorafenib-Associated HSFR in HCC

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: urea-based cream

• Registration Number: NCT01934829
• Lead Sponsor: Chinese Anti-Cancer Association

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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2013-08
• Study First Submitted: 2013-08-30
• Study First Submitted QC: 2013-08-30
• Last Update Submitted: 2013-08-30
• Study First Posted: 2013-09-04
• Last Update Posted: 2013-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 871

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
urea-based cream	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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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
The percentage of patients discontinuing treatment	starting sorafenib treatment within 12 weeks

Trial Locations

Locations (11)

Union Hospital of Fujian Medical University, Fujian, China; 🇨🇳 Fuzhou, Fujian, China

301 Military Hospital, Beijing, China; 🇨🇳 Beijing, Beijing, China

302 Military Hospital, Beijing, China; 🇨🇳 Beijing, Beijing, China

Guangdong Provincial People's Hospital, Guangdong, China; 🇨🇳 Guangzhou, Guangdong, China

The 81 Hospital of the Chinese People's Liberation Army, Nanjing, China; 🇨🇳 Nanjing, Jiangsu, China

Zhongshan Hospital, Fudan University, Shanghai; 🇨🇳 Shanghai, Shanghai, China

The Third Affiliated Hospital of Sun Yat-sen University, Guangdong, China; 🇨🇳 Guangzhou, Guangdong, China

Heilongjiang Provincial Cancer Hospital, Heilongjiang, China; 🇨🇳 Haerbin, Heilongjiang, China

Tianjin Cancer Hospital, Tianjin, China; 🇨🇳 Tianjin, Tianjin, China

Jilin Provincial Tumor Hospital, Jilin, China; 🇨🇳 Changchun, Jilin, China

Eastern Hepatobiliary Surgery Hospital of the Second Military Medical University, Shanghai, China; 🇨🇳 Shanghai, Shanghai, China