Urea Cream Treatment Sorafenib-Associated HSFR in HCC

August 30, 2013 updated by: Chinese Anti-Cancer Association

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

871

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • 301 Military Hospital, Beijing, China
      • Beijing, Beijing, China, 100039
        • 302 Military Hospital, Beijing, China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Union Hospital of Fujian Medical University, Fujian, China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People's Hospital, Guangdong, China
      • Guangzhou, Guangdong, China, 510630
        • The Third Affiliated Hospital of Sun Yat-sen University, Guangdong, China
    • Heilongjiang
      • Haerbin, Heilongjiang, China, 150081
        • Heilongjiang Provincial Cancer Hospital, Heilongjiang, China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • The 81 Hospital of the Chinese People's Liberation Army, Nanjing, China
    • Jilin
      • Changchun, Jilin, China, 130012
        • Jilin Provincial Tumor Hospital, Jilin, China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital, Fudan University, Shanghai
      • Shanghai, Shanghai, China, 200438
        • Eastern Hepatobiliary Surgery Hospital of the Second Military Medical University, Shanghai, China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Tianjin Cancer Hospital, Tianjin, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

Other Names:
  • Nexavar is the brand name of sorafenib
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of all-grade HFSR
Time Frame: Starting sorafenib treatment within 12 weeks
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
Starting sorafenib treatment within 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The percentage of patients requiring sorafenib dose-reduction
Time Frame: Starting sorafenib treatment within 12 weeks
Starting sorafenib treatment within 12 weeks
The percentage of patients requiring discontinuation of sorafenib therapy
Time Frame: starting sorafenib treatment within 12 weeks
starting sorafenib treatment within 12 weeks
The percentage of patients discontinuing treatment
Time Frame: starting sorafenib treatment within 12 weeks
starting sorafenib treatment within 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Anti-Cancer Association

Investigators

  • Principal Investigator: Sheng-Long Ye, PHD, Zhongshan Hospital, Fudan University, Shanghai, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

August 30, 2013

First Submitted That Met QC Criteria

August 30, 2013

First Posted (ESTIMATE)

September 4, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 4, 2013

Last Update Submitted That Met QC Criteria

August 30, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1163

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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