NCT01934829

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
871

participants targeted

Target at P75+ for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
Last Updated

September 4, 2013

Status Verified

August 1, 2013

Enrollment Period

1 year

First QC Date

August 30, 2013

Last Update Submit

August 30, 2013

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

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

Drug: urea-based cream

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

Interventions

urea-based creamDRUG

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.

Also known as: Nexavar is the brand name of sorafenib
urea-based cream

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

301 Military Hospital, Beijing, China

Beijing, Beijing Municipality, 100039, China

Location

302 Military Hospital, Beijing, China

Beijing, Beijing Municipality, 100039, China

Location

Union Hospital of Fujian Medical University, Fujian, China

Fuzhou, Fujian, 350001, China

Location

Guangdong Provincial People's Hospital, Guangdong, China

Guangzhou, Guangdong, 510080, China

Location

The Third Affiliated Hospital of Sun Yat-sen University, Guangdong, China

Guangzhou, Guangdong, 510630, China

Location

Heilongjiang Provincial Cancer Hospital, Heilongjiang, China

Haerbin, Heilongjiang, 150081, China

Location

The 81 Hospital of the Chinese People's Liberation Army, Nanjing, China

Nanjing, Jiangsu, 210002, China

Location

Jilin Provincial Tumor Hospital, Jilin, China

Changchun, Jilin, 130012, China

Location

Zhongshan Hospital, Fudan University, Shanghai

Shanghai, Shanghai Municipality, 200032, China

Location

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

Shanghai, Shanghai Municipality, 200438, China

Location

Tianjin Cancer Hospital, Tianjin, China

Tianjin, Tianjin Municipality, 300060, China

Location

Related Publications (5)

  • 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.

    PMID: 15831268RESULT

  • 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.

    PMID: 11668491RESULT

  • Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1.

    PMID: 14667750RESULT

  • 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.

    PMID: 9197213RESULT

  • 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.

    PMID: 3719551RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Sheng-Long Ye, PHD

    Zhongshan Hospital, Fudan University, Shanghai, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 4, 2013

Study Start

July 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

September 4, 2013

Record last verified: 2013-08

Locations

CN(11)