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Urea Cream Treatment Sorafenib-Associated HSFR in HCC

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
urea-based cream
Sponsored by
Chinese Anti-Cancer Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatocellular Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 301 Military Hospital, Beijing, China
  • 302 Military Hospital, Beijing, China
  • Union Hospital of Fujian Medical University, Fujian, China
  • Guangdong Provincial People's Hospital, Guangdong, China
  • The Third Affiliated Hospital of Sun Yat-sen University, Guangdong, China
  • Heilongjiang Provincial Cancer Hospital, Heilongjiang, China
  • The 81 Hospital of the Chinese People's Liberation Army, Nanjing, China
  • Jilin Provincial Tumor Hospital, Jilin, China
  • Zhongshan Hospital, Fudan University, Shanghai
  • Eastern Hepatobiliary Surgery Hospital of the Second Military Medical University, Shanghai, China
  • Tianjin Cancer Hospital, Tianjin, China

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

urea-based cream

best supportive care

Arm Description

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

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

Outcomes

Primary Outcome Measures

The incidence of all-grade HFSR
Prophylactic topical application of ointment to reduce the hand-foot skin reactions in patients with hepatocellular carcinoma treated with sorafenib

Secondary Outcome Measures

The percentage of patients requiring sorafenib dose-reduction
The percentage of patients requiring discontinuation of sorafenib therapy
The percentage of patients discontinuing treatment

Full Information

First Posted
August 30, 2013
Last Updated
August 30, 2013
Sponsor
Chinese Anti-Cancer Association
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1. Study Identification

Unique Protocol Identification Number
NCT01934829
Brief Title
Urea Cream Treatment Sorafenib-Associated HSFR in HCC
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chinese Anti-Cancer Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
871 (Actual)

8. Arms, Groups, and Interventions

Arm Title
urea-based cream
Arm Type
Experimental
Arm Description
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
Arm Title
best supportive care
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
urea-based cream
Other Intervention Name(s)
Nexavar is the brand name of sorafenib
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of all-grade HFSR
Time Frame
Starting sorafenib treatment within 12 weeks
Title
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 Outcome Measure Information:
Title
The percentage of patients requiring sorafenib dose-reduction
Time Frame
Starting sorafenib treatment within 12 weeks
Title
The percentage of patients requiring discontinuation of sorafenib therapy
Time Frame
starting sorafenib treatment within 12 weeks
Title
The percentage of patients discontinuing treatment
Time Frame
starting sorafenib treatment within 12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng-Long Ye, PHD
Organizational Affiliation
Zhongshan Hospital, Fudan University, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
301 Military Hospital, Beijing, China
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
302 Military Hospital, Beijing, China
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Union Hospital of Fujian Medical University, Fujian, China
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Guangdong Provincial People's Hospital, Guangdong, China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University, Guangdong, China
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
Heilongjiang Provincial Cancer Hospital, Heilongjiang, China
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
The 81 Hospital of the Chinese People's Liberation Army, Nanjing, China
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Jilin Provincial Tumor Hospital, Jilin, China
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Zhongshan Hospital, Fudan University, Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Eastern Hepatobiliary Surgery Hospital of the Second Military Medical University, Shanghai, China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China
Facility Name
Tianjin Cancer Hospital, Tianjin, China
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
15831268
Citation
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.
Results Reference
result
PubMed Identifier
11668491
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. doi: 10.1002/ijc.1440. No abstract available.
Results Reference
result
PubMed Identifier
14667750
Citation
Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1.
Results Reference
result
PubMed Identifier
9197213
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):1855-9. doi: 10.1056/NEJM199706263362602.
Results Reference
result
PubMed Identifier
3719551
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. doi: 10.1002/1097-0142(19860715)58:2+3.0.co;2-c.
Results Reference
result

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Urea Cream Treatment Sorafenib-Associated HSFR in HCC

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