Study Results
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Basic Information
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COMPLETED
NA
129 participants
INTERVENTIONAL
2014-03-21
2015-12-11
Brief Summary
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Detailed Description
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Patients
This study population consisted of patients with (1) HCC by proof of pathology, (2) 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, (3) Child-Pugh liver function class A, (4) planning to receive oral sorafenib 400 mg twice per day, (5) age of 20 or more years old, and (6) able to communication in Chinese, Taiwanese or Hakka. Patients with (1) encephalopathy, psychosis, cognition impairment, blindness or hearing impairment, (2) allergic history to urea, (3) present ulceration, blisters, infective problems on the palms or soles, or (4) previous surgery, systematic chemotherapy or frequent radial ablation were excluded.
Research procedure
This is a randomized double-blind experiment study. Sample size was estimated by the G. power software version 3.1, which was set with logistic regression, odds ratio: 3.8, and power: 0.80. The estimated sample size should be 125 at least. This study, there was recruited 129 patients (43 patients in each groups). All eligible patients were recruited from Taipei Veterans General Hospital between January 1st and December 31th, 2014. They were randomly assigned in a ratio of 1:1:1 to treat with best supportive care plus moisturizing cream (A group), BSC plus 10% urea-based cream (B group) and BSC alone (group C which is comparison group),by method of EXCEL random sampling. A case manager recruited the eligible patients who also conducted informed consent and patient education. A research employee had responsibilities to record patients' demographic data, provide non-label cream and check previous container of the cream that should be exhausted. A medical oncologist or a nurse had responsibilities to assess patients' severity of HFSR and cutaneous wetness. The assessment was done on 3 days before starting sorafenib treatment and each 7 days after the starting, total 9 times. Creams were provided after the assessment. When patients developed HFSR, they will be referred to receive the most appropriate management.
Interventions
Interventions for group C (comparison group) 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. 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. A 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.
Outcomes and assessment
Data of con founders and two end-points, incidence density of HFSR and cutaneous wetness, were collected. The con-founders included gender, age, numbers of chronic illnesses, numbers of metastatic regions as well as levels of white count, hemoglobin, bleeding time, liver enzymes, albumin and electrolyte.
The grades of HFSR were assessed by NCI-CTCAE version 4, which was developed by Dueck et al. This is an available psychometric patient-reported instrument. Body water with 33% or less meant dry skin, 34% to 37% meant mild dry skin, 38% to 42% meant general status, 43% to 46/% was mild moisty skin and 47% or more presented moisty skin. When using the scanner, examiners had to confirm whether it tied to fix on the skin.
Ethical considerations
This study was approved by the Institution Review Board of the Taipei Veterans General Hospital (2013-13-009B). Informed consent was obtained from all patients by a case manager on 3 days before starting sorafenib. Patients were explained the study protocol and were educated self-care skills by the case manager. All of them were well aware that their rights will be protected, the risk of participation will be limited to the lowest and most suitable management will be arranged when they developed sorafenib-induced HFSR.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Best support care (BSC)
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.
best support care
Best support care
BSC plus moisture cream
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.
moisture cream
BSC plus moisture cream
10% urea-based cream
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.
10% urea-based cream
BSC plus 10% urea-based cream.
Interventions
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best support care
Best support care
moisture cream
BSC plus moisture cream
10% urea-based cream
BSC plus 10% urea-based cream.
Eligibility Criteria
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Inclusion Criteria
* 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
* Allergic history to urea
* Present ulceration, blisters, infective problems on the palms or soles
* Previous surgery, systematic chemotherapy or frequent radial ablation
54 Years
91 Years
ALL
No
Sponsors
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Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Responsible Party
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Jiin Ger, MD
Taipei Veterans General Hospital
References
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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.
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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.
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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.
Other Identifiers
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2013-11-009
Identifier Type: -
Identifier Source: org_study_id
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