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

NCT03212625 | Completed Phase 4

• 1 other identifier: KUGH15337
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma

Keywords

Urea Cream; Sorafenib

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of Hand-Foot Skin Reaction(HFSR) on each group

  Comparison of cumulative incidence of HFSR between placebo group and urea cream group

  12 weeks treatment

Secondary Outcomes (7)

• Cumulative incidence of severe HFSR on each group

  12 weeks treatment

• Incidence of dose reduction or discontinuation of sorafenib due to HFSR on each group

  12 weeks treatment

• Assessment of Quality Of Life (QOL)

  12 weeks treatment

• Overall survival

  12 weeks treatment

• Tumor response

  12 weeks treatment

Study Arms (2)

Urea cream 20%

EXPERIMENTAL

144 patients spread urea cream (urea 20%)

Drug: Urea Cream 20%

Placebo

PLACEBO COMPARATOR

144 patients spread placebo cream (urea 0%)

Drug: Placebos

Interventions

Urea Cream 20% DRUG

Sorafenib 400mg (twice daily), Spread urea cream (urea 20%)

Also known as: Urea group

Urea cream 20%

Placebos DRUG

Sorafenib 400mg (twice daily), Spread placebo cream (urea 0%)

Also known as: Placebo group

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Suitable on hepatocellular carcinoma pathologically
• 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)
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Korea University Guro Hospital: lead
• Hanmi Pharmaceutical Company Limited: collaborator

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Related Publications (11)

• Wilhelm SM, Carter C, Tang L, Wilkie D, McNabola A, Rong H, Chen C, Zhang X, Vincent P, McHugh M, Cao Y, Shujath J, Gawlak S, Eveleigh D, Rowley B, Liu L, Adnane L, Lynch M, Auclair D, Taylor I, Gedrich R, Voznesensky A, Riedl B, Post LE, Bollag G, Trail PA. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res. 2004 Oct 1;64(19):7099-109. doi: 10.1158/0008-5472.CAN-04-1443.

  PMID: 15466206 BACKGROUND

• Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.

  PMID: 18650514 BACKGROUND

• Bruix J, Sherman M; American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011 Mar;53(3):1020-2. doi: 10.1002/hep.24199. No abstract available.

  PMID: 21374666 BACKGROUND

• Chu D, Lacouture ME, Fillos T, Wu S. Risk of hand-foot skin reaction with sorafenib: a systematic review and meta-analysis. Acta Oncol. 2008;47(2):176-86. doi: 10.1080/02841860701765675.

  PMID: 18210295 BACKGROUND

• Zhang L, Zhou Q, Ma L, Wu Z, Wang Y. Meta-analysis of dermatological toxicities associated with sorafenib. Clin Exp Dermatol. 2011 Jun;36(4):344-50. doi: 10.1111/j.1365-2230.2011.04060.x. Epub 2011 Apr 20.

  PMID: 21507035 BACKGROUND

• Iijima M, Fukino K, Adachi M, Tsukamoto T, Murai M, Naito S, Minami H, Furuse J, Akaza H. Sorafenib-associated hand-foot syndrome in Japanese patients. J Dermatol. 2011 Mar;38(3):261-6. doi: 10.1111/j.1346-8138.2010.01059.x. Epub 2010 Nov 2.

  PMID: 21342228 BACKGROUND

• Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. doi: 10.1016/S1470-2045(08)70285-7. Epub 2008 Dec 16.

  PMID: 19095497 BACKGROUND

• Ren Z, Zhu K, Kang H, Lu M, Qu Z, Lu L, Song T, Zhou W, Wang H, Yang W, Wang X, Yang Y, Shi L, Bai Y, Guo X, Ye SL. Randomized controlled trial of the prophylactic effect of urea-based cream on sorafenib-associated hand-foot skin reactions in patients with advanced hepatocellular carcinoma. J Clin Oncol. 2015 Mar 10;33(8):894-900. doi: 10.1200/JCO.2013.52.9651. Epub 2015 Feb 9.

  PMID: 25667293 BACKGROUND

• Lacouture ME, Wu S, Robert C, Atkins MB, Kong HH, Guitart J, Garbe C, Hauschild A, Puzanov I, Alexandrescu DT, Anderson RT, Wood L, Dutcher JP. Evolving strategies for the management of hand-foot skin reaction associated with the multitargeted kinase inhibitors sorafenib and sunitinib. Oncologist. 2008 Sep;13(9):1001-11. doi: 10.1634/theoncologist.2008-0131. Epub 2008 Sep 8.

  PMID: 18779536 BACKGROUND

• Anderson RT, Keating KN, Doll HA, Camacho F. The Hand-Foot Skin Reaction and Quality of Life Questionnaire: An Assessment Tool for Oncology. Oncologist. 2015 Jul;20(7):831-8. doi: 10.1634/theoncologist.2014-0219. Epub 2015 Jun 17.

  PMID: 26084809 BACKGROUND

• Lee YS, Jung YK, Kim JH, Cho SB, Kim DY, Kim MY, Kim HJ, Seo YS, Yoon KT, Hong YM, Lee JH, Lee HW, Yim HJ, Jang BK, Jang ES, Jang JY, Hwang SY. Effect of urea cream on sorafenib-associated hand-foot skin reaction in patients with hepatocellular carcinoma: A multicenter, randomised, double-blind controlled study. Eur J Cancer. 2020 Nov;140:19-27. doi: 10.1016/j.ejca.2020.09.012. Epub 2020 Oct 8.

  PMID: 33039810 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Ji Hoon Kim, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 2, 2017
• First Posted: July 11, 2017
• Study Start: January 28, 2016
• Primary Completion: September 20, 2018
• Study Completion: September 20, 2018
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)