Clinical trial · Interventional
Prevention of Hand-foot Skin Reaction
Re-validating Prophylactic Efficacy of Urea-based Cream on Sorafenib-induced Hand-foot Skin Reaction in Patients With Advanced Hepatocellular Carcinoma
NCT04568330CI-TRIAL-00047379completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Sorafenib-induced hand-foot skin reaction (HFSR) is a dose-dependent side effect in patients with advance hepatocellular carcinoma (HCC). The appropriate prophylactic dose of urea-based cream and comparison of its effectiveness with other creams remain unclear. The aim of this study was re-validating the prophylactic HFSR incidence density and cutaneous wetness of 10% urea-based cream on sorafenib-induced HFSR in patients with advanced HCC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 10% urea-based cream | Other | — | UNRESOLVED |
| best support care | Other | — | UNRESOLVED |
| moisture cream | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Best support care (BSC)
- description
- Interventions for comparison group (group C) who received BSC alone were (1) informed of potential presentations of HFSR, (2) asked for wearing waterproof gloves before execute household or work with water, (3) provided the method of contacting with healthcare specialists for confirming early diagnosis of HFSR, and (4) asked for self-report when they occurred symptoms of HFSR.
- interventionNames
- Other: best support care
- type
- EXPERIMENTAL
- label
- BSC plus moisture cream
- description
- The A group with BCS plus moisturizing cream received the interventions as the comparison group, was given the moisturizing cream (dimethicone, fragrance free, Aveeno, United States) for 9 times and was instructed how to use the cream. The education of usage included (1) using the cream twice a day from 3 days before starting sorafenib and each week post starting sorafenib, (2) scooping out nut-sized cream with a unique spoon each time, (3) gently applied the cream evenly on symmetrical palms below wrists and symmetrical soles below ankles each time, (4) wore unique cotton gloves immediately after the appalment of cream for 30 minutes each time.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 54 Years
- Maximum age
- 91 Years
Show eligibility criteria text
Inclusion Criteria: * HCC by proof of pathology * Presence of tumor thrombus in the main trunk of the portal vein or the first-order branches of the portal vein with minimal ascetics or with no ascetics by abdominal CT scan * Child-Pugh liver function class A * Planning to receive oral sorafenib 400 mg twice per day * Age of 20 or more years old * Able to communication in Chinese, Taiwanese or Hakka Exclusion Criteria: * Encephalopathy, psychosis, cognition impairment, blindness or hearing impairment * Allergic history to urea * Present ulceration, blisters, infective problems on the palms or soles * Previous surgery, systematic chemotherapy or frequent radial ablation
References
Publications (21)
- BACKGROUNDCheng 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
- BACKGROUNDBenson AB 3rd, Abrams TA, Ben-Josef E, Bloomston PM, Botha JF, Clary BM, Covey A, Curley SA, D'Angelica MI, Davila R, Ensminger WD, Gibbs JF, Laheru D, Malafa MP, Marrero J, Meranze SG, Mulvihill SJ, Park JO, Posey JA, Sachdev J, Salem R, Sigurdson ER, Sofocleous C, Vauthey JN, Venook AP, Goff LW, Yen Y, Zhu AX. NCCN clinical practice guidelines in oncology: hepatobiliary cancers. J Natl Compr Canc Netw. 2009 Apr;7(4):350-91. doi: 10.6004/jnccn.2009.0027. No abstract available. PMID 19406039
- BACKGROUNDKao PH, Cen JS, Chung WH. Cutaneous adverse events of targeted anticancer therapy: a review of common clinical manifestations and management. J Cancer Res Pract. 2015; 2(4): 271-284.
- BACKGROUNDWood LS, Lemont H, Jatoi A. Practical considerations in the management of hand-foot skin reaction caused by multikinase inhibitors. Commun Oncol .2010; 7: 23-39
- RESULTBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
- RESULTEuropean Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. doi: 10.1016/j.jhep.2018.03.019. Epub 2018 Apr 5. No abstract available. PMID 29628281
- RESULTLlovet 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.