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Urea Cream Treatment Sorafenib-Associated HSFR in HCC

NCT01934829 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 871

Last updated 2013-09-04

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Chinese Anti-Cancer Association

    lead OTHER

Principal Investigators

  • Sheng-Long Ye, PHD · Zhongshan Hospital, Fudan University, Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01934829 on ClinicalTrials.gov