Prevention of Hand-foot Skin Reaction

NCT04568330 | Completed

• 1 other identifier: 2013-11-009
• Study Type: interventional
• Target: 129
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Hepatocellular Carcinoma

Keywords

hand-foot skin reaction; side effect of sorafenib; symptom related to target therapy; efficacy of urea-based cream; symptom management

Outcome Measures

Primary Outcomes (1)

• Scale

  National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0

  three days before taking Sorafenib

Secondary Outcomes (1)

• Scale

  1 week after taking Sorafenib

Other Outcomes (7)

• Scale

  2 week after taking Sorafenib

• Scale

  3 week after taking Sorafenib

• Scale

  4 week after taking Sorafenib

Study Arms (3)

Best support care (BSC)

OTHER

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.

Other: best support care

BSC plus moisture cream

EXPERIMENTAL

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.

Other: moisture cream

10% urea-based cream

ACTIVE COMPARATOR

The B group with BCS plus 10% urea-based cream had the similar interventions as the A group with BCS plus moisturizing cream except being given the cream container with different component (10% urea; Sipharr, Taiwan). The outlook of the containers with the two kinds of cream was the same. All the cream looks white and grey.

Other: 10% urea-based cream

Interventions

best support care OTHER

Best support care

Best support care (BSC)

moisture cream OTHER

BSC plus moisture cream

BSC plus moisture cream

10% urea-based cream OTHER

BSC plus 10% urea-based cream.

10% urea-based cream

Eligibility Criteria

• Age: 54 Years - 91 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Related Publications (21)

• 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

• Benson 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 BACKGROUND

• Kao 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.

  BACKGROUND

• Wood 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

  BACKGROUND

• Bray 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 RESULT

• European 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 RESULT

• 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 RESULT

• Cubero DIG, Abdalla BMZ, Schoueri J, Lopes FI, Turke KC, Guzman J, Del Giglio A, Filho CDSM, Salzano V, Fabra DG. Cutaneous side effects of molecularly targeted therapies for the treatment of solid tumors. Drugs Context. 2018 Jul 17;7:212516. doi: 10.7573/dic.212516. eCollection 2018.

  PMID: 30038659 RESULT

• Lipworth AD, Robert C, Zhu AX. Hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia): focus on sorafenib and sunitinib. Oncology. 2009;77(5):257-71. doi: 10.1159/000258880. Epub 2009 Nov 16.

  PMID: 19923864 RESULT

• Massey PR, Okman JS, Wilkerson J, Cowen EW. Tyrosine kinase inhibitors directed against the vascular endothelial growth factor receptor (VEGFR) have distinct cutaneous toxicity profiles: a meta-analysis and review of the literature. Support Care Cancer. 2015 Jun;23(6):1827-35. doi: 10.1007/s00520-014-2520-9. Epub 2014 Dec 5.

  PMID: 25471178 RESULT

• Chang WT, Lu SN, Rau KM, Huang CS, Lee KT. Increased cumulative doses and appearance of hand-foot skin reaction prolonged progression free survival in sorafenib-treated advanced hepatocellular carcinoma patients. Kaohsiung J Med Sci. 2018 Jul;34(7):391-399. doi: 10.1016/j.kjms.2018.03.006. Epub 2018 Apr 4.

  PMID: 30063012 RESULT

• Macdonald JB, Macdonald B, Golitz LE, LoRusso P, Sekulic A. Cutaneous adverse effects of targeted therapies: Part I: Inhibitors of the cellular membrane. J Am Acad Dermatol. 2015 Feb;72(2):203-18; quiz 219-20. doi: 10.1016/j.jaad.2014.07.032.

  PMID: 25592338 RESULT

• Manchen E, Robert C, Porta C. Management of tyrosine kinase inhibitor-induced hand-foot skin reaction: viewpoints from the medical oncologist, dermatologist, and oncology nurse. J Support Oncol. 2011 Jan-Feb;9(1):13-23. doi: 10.1016/j.suponc.2010.12.007.

  PMID: 21465734 RESULT

• 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 RESULT

• Negri FV, Porta C. Urea-Based Cream to Prevent Sorafenib-Induced Hand-and-Foot Skin Reaction: Which Evidence? J Clin Oncol. 2015 Oct 1;33(28):3219-20. doi: 10.1200/JCO.2015.61.6417. Epub 2015 Jul 27. No abstract available.

  PMID: 26215963 RESULT

• Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.

  PMID: 19897823 RESULT

• Dueck AC, Mendoza TR, Mitchell SA, Reeve BB, Castro KM, Rogak LJ, Atkinson TM, Bennett AV, Denicoff AM, O'Mara AM, Li Y, Clauser SB, Bryant DM, Bearden JD 3rd, Gillis TA, Harness JK, Siegel RD, Paul DB, Cleeland CS, Schrag D, Sloan JA, Abernethy AP, Bruner DW, Minasian LM, Basch E; National Cancer Institute PRO-CTCAE Study Group. Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JAMA Oncol. 2015 Nov;1(8):1051-9. doi: 10.1001/jamaoncol.2015.2639.

  PMID: 26270597 RESULT

• Piccoli A, Rossi B, Pillon L, Bucciante G. A new method for monitoring body fluid variation by bioimpedance analysis: the RXc graph. Kidney Int. 1994 Aug;46(2):534-9. doi: 10.1038/ki.1994.305. No abstract available.

  PMID: 7967368 RESULT

• Shinohara N, Nonomura N, Eto M, Kimura G, Minami H, Tokunaga S, Naito S. A randomized multicenter phase II trial on the efficacy of a hydrocolloid dressing containing ceramide with a low-friction external surface for hand-foot skin reaction caused by sorafenib in patients with renal cell carcinoma. Ann Oncol. 2014 Feb;25(2):472-6. doi: 10.1093/annonc/mdt541. Epub 2013 Dec 18.

  PMID: 24351402 RESULT

• Barton-Burke M, Ciccolini K, Mekas M, Burke S. Dermatologic Reactions to Targeted Therapy: A Focus on Epidermal Growth Factor Receptor Inhibitors and Nursing Care. Nurs Clin North Am. 2017 Mar;52(1):83-113. doi: 10.1016/j.cnur.2016.11.005.

  PMID: 28189168 RESULT

• Lien RY, Tung HH, Wu SL, Hu SH, Lu LC, Lu SF. Validation of the prophylactic efficacy of urea-based creams on sorafenib-induced hand-foot skin reaction in patients with advanced hepatocellular carcinoma: A randomised experiment study. Cancer Rep (Hoboken). 2022 Jul;5(7):e1532. doi: 10.1002/cnr2.1532. Epub 2021 Dec 14.

  PMID: 34910380 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Taipei Veterans General Hospital

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 29, 2020
• Study Start: March 21, 2014
• Primary Completion: November 11, 2015
• Study Completion: December 11, 2015
• Last Updated: September 29, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share