Hepatocellular Carcinoma Clinical Trial
Official title:
The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction in Patients With Korean Hepatocellular Carcinoma Patients: Multicenter, Prospective Randomized Double-Blind Controlled Study
Verified date | August 2019 |
Source | Korea University Guro Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 288 |
Est. completion date | September 20, 2018 |
Est. primary completion date | September 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Guro Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Korea University Guro Hospital | Hanmi Pharmaceutical Company Limited |
Korea, Republic of,
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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, Häussinger 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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Cumulative incidence of severe HFSR on each group | Comparison of cumulative incidence of severe HFSR (grade 2 or grade 3) between placebo group and urea cream group | 12 weeks treatment | |
Secondary | Incidence of dose reduction or discontinuation of sorafenib due to HFSR on each group | Comparison of incidence of dose reduction or discontinuation of sorafenib due to HFSR on each group | 12 weeks treatment | |
Secondary | Assessment of Quality Of Life (QOL) | Assessment of QOL related to HFSR using The Hand-Foot Skin Reaction and Quality of Life Questionnaire (HF-QoL) scoring system. HF-QOL instrument comprises a 20-item symptom scale and an 18-item daily activity scale. Each item was scored from 0 (not at all) to 4 (always or extremely). Therefore, the range of score for HF-QoL was from 0 to 152 points. (Ref. Anderson et al. The Oncoligist 2015;20:831-838) | 12 weeks treatment | |
Secondary | Overall survival | Overall survival of patients | 12 weeks treatment | |
Secondary | Tumor response | Tumor response using mRECIST criteria | 12 weeks treatment | |
Secondary | Other side effect | The occurrence rate of other side effect excluding HFSR | 12 weeks treatment | |
Secondary | Incidence of HFSR on 2, 4, 8, and 12 weeks on each group | Comparison of incidence of HFSR on 2, 4, 8, and 12 weeks between placebo group and urea cream group | 2, 4, 8, and 12 weeks |
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