The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction

• Status: Completed
• Trial end date: 2018-09-20
• Target enrollment: 0
• Participant gender: All

Summary

Many investigators have studied for prevention and care of Hand-Foot Skin Reaction(HFSR), and urea cream is typical representative. Recent study was performed prevention effect of urea cream for Hand-Foot Skin Reaction(HFSR) on 871 Chinese. But the study did not designed as placebo-control group and it had big defect in double-blinded.

Therefore, it needs complementary study as double-blinded placebo-controlled trial and effect of urea cream on Korean patient group.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea University Guro Hospital
• Collaborator: Hanmi Pharmaceutical Company Limited
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Patient who was diagnosed with hepatocellular carcinoma, and was accompanied by impossible for radical treatment in disease period or do not reaction for local treatment, and the first time for sorafenib injection.

• Standard of hepatocellular carcinoma diagnosis (2014, The Korean Liver Cancer Association)

1. Suitable on hepatocellular carcinoma pathologically

2. Hepatic nodule size over 1 cm on high-risk patients(hepatitis B virus positive, hepatitis C virus positive and liver cirrhosis) that identified by ultrasonography : In the case of suitable on hepatocellular carcinoma on over in one or two more dynamic contrast enhanced CT, dynamic contrast enhanced MRI, or MRI with Gadolinium Ethoxybenzyl Diethylenetriamine Pentaacetic Acid(Gd-EOB-DTPA)

3. Hepatic nodule size under 1 cm on high-risk patients that identified by ultrasonography : serum Alpha-fetoprotein(AFP) elevated over normal range constantly when hepatitis activity was restrained, and the case of suitable on hepatocellular carcinoma on over in two more the above image diagnoses

Exclusion Criteria:

• Unsuitable on inclusion criteria

• Patient who has had systemic anticancer therapy before (including sorafenib)

• Patient who is receiving another treatment to hepatocellular carcinoma recent 3 weeks (allow to local treatment of metastasis lesion only)

• Pregnant or Breastfeeding

• Urea cream contraindication patient (Acute eczema, Inflammatory dermatopathy and Hypersensitivity on Urea and Methylparaben)